Archive for January, 2015
(CRRC) To Be Acquired By Quad/Graphics as Part of Strategy to Transform Book Platform
Quad/Graphics, Inc. (NYSE: QUAD) (“Quad/Graphics” or the “Company”) and Courier Corporation (Nasdaq: CRRC) (“Courier”) jointly announced a definitive agreement by which Quad/Graphics will acquire Courier, a leading innovator in book manufacturing, publishing and content management. The acquisition accelerates Quad/Graphics’ three-year strategy to transform its book platform, which the Company announced earlier this week.
Under terms of the agreement, Quad/Graphics will acquire Courier in a transaction valued at approximately $260 million, including approximately $25 million in net debt and capital leases as of December 31, 2014. Quad/Graphics will pay Courier shareholders the equivalent of a total purchase price of $20.50 per share, consisting of cash and shares of Quad/Graphics Class A common stock. Each Courier shareholder will have the right to elect to receive cash or Quad/Graphics common stock, subject to proration in the event that shareholders elect to receive more than 54% cash or more than 46% stock. Quad/Graphics will pay an aggregate amount consisting of approximately $129 million in cash and approximately 4.8 million shares.
The transaction has been approved by both companies’ boards of directors and is subject to customary closing conditions, including regulatory approval and approval by Courier’s shareholders. Quad/Graphics expects the acquisition to close by mid-year, be accretive to earnings in 2016, and that the purchase price multiple will be less than five times Adjusted EBITDA after taking into account anticipated synergies. Upon closing of the transaction, James F. Conway III will join Quad/Graphics as President of the Book Division.
“We are excited about the opportunities ahead with Courier as part of our Company, and the value it creates for both our companies’ clients and shareholders,” said Joel Quadracci, Quad/Graphics Chairman, President & CEO. “Courier has a legacy of superior quality and exceptional customer service, and is a well-known innovator in every aspect of book production, from content management to printing, binding, distribution and integration with electronic media.”
Courier was an early adopter of the digital print technology that is rapidly changing the dynamics of the book industry, Quadracci explained. “Using digital technology, Courier pioneered the development of customization solutions that now bring class-specific versions of academic textbooks to millions of students each year. The company has continually reinvested in its platform, and with our previously announced investment in 20-plus digital presses and integrated systems, together we will accelerate a broad industry transition to a print-on-demand, zero-inventory model.”
Said James F. Conway III, Courier’s Chairman, President and CEO: “After a careful and thorough evaluation process, the Courier board has determined that the transaction with Quad/Graphics maximizes value for our shareholders. The board strongly believes that this transaction achieves that result, providing a substantial premium for our shareholders.”
Conway continued: “I am delighted to bring Courier together with another company that shares our values, offers complementary capabilities and opens up a world of additional opportunities. We are confident that the combination of our two companies will create the most opportunities for customers and employees well into the future. Like Courier, Quad/Graphics represents the very best in technology and service for the 21st-century marketplace. The addition of Courier’s four-color offset presses, digital inkjet presses, end-to-end process management and integrated software solutions further enhances Quad/Graphics’ efforts to transform the book industry to the benefit of publishers and readers everywhere.”
“We look forward to welcoming Courier’s clients and employees to Quad and redefining the book supply chain for the benefit of publishers everywhere,” Quadracci said.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These forward-looking statements, which are based on current expectations, estimates and projections about the industry and markets in which Quad/Graphics and Courier operate and beliefs of and assumptions made by Quad/Graphics management and Courier management, involve uncertainties that could significantly affect the financial results of Quad/Graphics or Courier or the combined company. Words such as “aim,” “expect,” “anticipate,” “intend,” “plan,” “goal,” “believe,” “hope,” “seek,” “target,” “continue,” “estimate,” “will,” “may,” “would,” “could,” “should,” or variations of such words and similar expressions or the negative thereof are intended to identify such forward-looking statements, which generally are not historical in nature. Such forward-looking statements include, but are not limited to, statements regarding the financial condition, results of operations and business of Quad/Graphics and Courier and the combined businesses of Quad/Graphics and Courier and certain plans and objectives of Quad/Graphics and Courier with respect thereto, including the expected benefits of the proposed transactions. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future — including statements relating to expected synergies, improved liquidity and balance sheet strength — are forward-looking statements. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. Although we believe the expectations reflected in any forward-looking statements are based on reasonable assumptions, we can give no assurance that our expectations will be attained and therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. Some of the factors that may affect outcomes and results include, but are not limited to: (i) national, regional and local economic climates, (ii) changes in financial markets and interest rates, (iii) increased or unanticipated competition, (iv) risks associated with acquisitions, (v) availability of financing and capital, (vi) risks associated with achieving expected revenue synergies or cost savings, (vii) risks associated with the ability to consummate the transaction and the timing of the closing of the transaction, (viii) risks associated with the integration of Quad/Graphics’ and Courier’s respective businesses, and (ix) those additional risks and factors discussed in reports filed with the Securities and Exchange Commission (“SEC”) by Quad/Graphics and Courier from time to time, including those discussed under the heading “Risk Factors” in their respective most recently filed reports on Form 10-K and 10-Q. Neither Quad/Graphics nor Courier undertakes any duty to update any forward-looking statements appearing in this document.
Additional Information about the Proposed Transaction and Where to Find It:
In connection with the proposed transaction, Quad/Graphics expects to file with the SEC a registration statement on Form S-4 that will include a proxy statement of Courier that also constitutes a prospectus of Quad/Graphics. Courier will mail the proxy statement/prospectus to its shareholders. Quad/Graphics and Courier also plan to file other relevant documents with the SEC regarding the proposed transaction. INVESTORS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC IF AND WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. You may obtain a free copy of the proxy statement/prospectus (if and when it becomes available) and other relevant documents filed by Quad/Graphics and Courier with the SEC at the SEC’s website at www.sec.gov. Copies of the documents filed by Quad/Graphics with the SEC will be available free of charge on Quad/Graphics’ website at www.QG.com or by contacting Quad/Graphics Investor Relations at IR@qg.com. Copies of the documents filed by Courier with the SEC will be available free of charge on Courier’s website at www.courier.com or by contacting Courier Investor Relations at investorrelations@courier.com.
This communication is not a solicitation of a proxy from any investor or shareholder. However, Courier and certain of its directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. You can find information about Courier’s executive officers and directors in Courier’s annual report on Form 10-K filed on December 1, 2014, and its definitive proxy statement filed with the SEC on December 10, 2013. Additional information regarding the interests of such potential participants will be included in the proxy statement/prospectus and other relevant documents filed with the SEC if and when they become available. You may obtain free copies of these documents from Courier using the sources indicated above.
This document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.
About Quad/Graphics
Quad/Graphics (NYSE: QUAD), a leading global printer, is redefining print in today’s multichannel media world by helping marketers and publishers capitalize on print’s ability to complement and connect with other media channels. With consultative ideas, worldwide capabilities, leading-edge technology and single-source simplicity, Quad/Graphics has the resources and knowledge to help its clients maximize the revenue they derive from their marketing spend through channel integration, and minimize their total cost of print production and distribution through a fully integrated national distribution network. The Company provides a diverse range of print solutions, media solutions and logistics services from multiple locations throughout North America, Latin America and Europe.
About Courier Corporation
Courier Corporation is America’s second largest book manufacturer and a leader in content management and customization in new and traditional media. It also publishes books under two brands offering award-winning content and thousands of titles. Founded in 1824, Courier is headquartered in North Chelmsford, Massachusetts. For more information, visit www.courier.com.
Quad/Graphics Media Contact:
Claire Ho, 414-566-2955
Quad/Graphics Director of Corporate Communications
Claire.Ho@qg.com
or
Quad/Graphics Investor Relations Contact:
Kelly Vanderboom, 414-566-2464
Quad/Graphics Vice President & Treasurer
Kelly.Vanderboom@qg.com
or
Courier Investor Relations Contact:
Peter Folger, 978-251-6000
Courier Senior Vice President and Chief Financial Officer
investorrelations@courier.com
or
Courier Media Contact:
Wilkinson Brimmer Katcher
Averell Withers or Nick Leasure at Joele Frank, 212-355-4449
(JRJC) Strategic Partnership with China International Capital Corp.
Securities Master Financial Technology Continues to Gain Traction in China
BEIJING, Jan. 15, 2015 — China Finance Online Co. Limited (“China Finance Online”, or the “Company”) (NASDAQ GS: JRJC), a leading web-based financial services company that provides Chinese retail investors online access to securities, commodities and wealth management products, today announced that it has entered into a strategic partnership agreement with China International Capital Corporation Limited (“CICC “), which is a top global securities and investment firm from China.
Mr. Zhiwei Zhao, Chairman and CEO of China Finance Online, commented, “We are happy that CICC chose China Finance Online as its strategic partner to extend its online brokerage business. We believe this success demonstrates the superior technical innovation as well as capital market and online brokerage experience that underlie our ability to make online brokerage services in China a reality. Looking ahead, we will continue to leverage our unique advantages and forge win-win partnerships to build an investment ecosystem in China that offers beneficial investment services to China’s growing population of retail investors, and support our ability to expand our market-share and generate returns for our shareholders and partners.”
About China International Capital Corporation Limited
China International Capital Corporation Limited (CICC) was established in July 1995 as a strategic partnership among prestigious Chinese and international financial institutions. CICC has a registered capital of US$225 million. As the first joint venture investment bank in China, CICC is a leader in providing comprehensive financial services including investment banking, capital markets, institutional and individual securities sales and trading, fixed income, asset management, private equity, wealth management and research. Headquartered in Beijing, CICC has set up three branches in Shanghai and Shenzhen, several subsidiaries in mainland China, and securities brokerage branches in 18 cities such as Beijing, Shanghai and Shenzhen. In line with increasing business diversity, the company is actively expanding overseas while consolidating its Chinese base in Hong Kong, New York, London and Singapore.
About China Finance Online
China Finance Online Co. Limited is a leading web-based financial services company in China. The company provides Chinese retail investors with online access to securities, commodities and wealth management products, as well as financial database and analytics services to institutional customers. The Company’s two prominent flagship portal sites, www.jrj.com and www.stockstar.com, are ranked among the top financial websites in China. In addition to the web-based securities trading platform, the Company offers basic financial software, information services and securities investment advisory services to retail investors in China. Through its subsidiary, Shenzhen Genius Information Technology Co., Ltd., the Company provides financial database and analytics to institutional customers including domestic financial, research, academic and regulatory institutions. China Finance Online also provides brokerage services in Hong Kong. For more information, please visit http://www.chinafinanceonline.com/.
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, this release contains the following forward-looking statements regarding:
— our prospect on the growth of our financial platform and online trading capabilities;
— our prospect on the cooperation with CICC and our partnered securities firms and expanding the number of partnered securities firms;
— our prospect on continuing to innovate and forge successful partnerships; and
— the market prospect of the business of Internet finance.
Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, which risks and uncertainties include, among others, the following:
— the changing customer needs, regulatory environment and market condition that we are subject to;
— the uneven condition of the world and Chinese economy that could lead to volatility in the equity markets and affect our operating results in the coming quarters;
— the impact of the changing conditions of the Chinese stock market, Hong Kong stock market and global financial market on our future performance;
— the unpredictability of our strategic transformation and growth of new businesses, including our online securities trading services and platform;
— the degree to which our strategic collaborations with partners will yield successful outcome;
— the prospect for China’s high-net-worth and middle-class households;
— the prospect of equipping our customer specialists with new technology, tools and financial knowledge;
— the competition we are facing in the new business of Internet finance and online securities trading;
— wavering investor confidence that could impact our business; and
— possible non-cash goodwill, intangible assets and investment impairment may adversely affect our net income.
Further information regarding these and other risks is included in the Company’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F under “Forward-Looking Information” and “Risk Factors”. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.
(FLML) Price Change for Bloxiverz
LYON, FRANCE–(Jan 15, 2015) – Flamel Technologies (NASDAQ: FLML) today announced that the Wholesale Acquisition Cost (WAC) for Bloxiverz has been increased to $98.75 per vial for both the 0.5 and 1.0 mg/mL strengths. Bloxiverz (neostigmine methylsulfate), which Flamel launched in July 2013, is used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.
About Flamel Technologies – Flamel Technologies SA’s (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The Company markets Bloxiverz™ (neostigmine methylsulfate) and Vazculep™ (phenylephrine hydrochloride) in the US and licenses the Micropump-based microparticles technology to Recipharm AB for application to the manufacturing under FDA-audited GMP guidelines of Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its pipeline includes chemical and biological drugs formulated with its Micropump® (and its applications to the development of liquid formulations LiquiTime® and of abuse-deterrent formulations Trigger Lock™) and Medusa™ proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and Dublin, Ireland. Additional information may be found at www.flamel.com.
Safe Harbor: This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including certain plans, expectations, goals and projections regarding financial results, product developments and technology platforms. All statements that are not clearly historical in nature are forward-looking, and the words “anticipate,” “assume,” “believe,” “expect,” “estimate,” “plan,” “will,” “may,” and similar expressions are generally intended to identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that the launch of Bloxiverz™ and Vazculep™ will not be as successful as anticipated; our ability to bring other R&D projects of the former Éclat Pharmaceuticals to market may be unsuccessful; clinical trial results may not be positive or our partners may decide not to move forward; products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements; products in development may not achieve market acceptance; competitive products and pricing may hinder our commercial opportunities; we may not be successful in identifying and pursuing opportunities to develop our own product portfolio using Flamel’s technology; and the risks associated with our reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel’s Annual Report on Form 20-F for the year ended December 31, 2013 that has been filed with the Securities and Exchange Commission (SEC). All forward-looking statements included in this release are based on information available at the time of the release. We undertake no obligation to update or alter our forward-looking statements as a result of new information, future events or otherwise
(NVGN) Announces Important Discovery in Regenerative Medicine Program
SYDNEY, Jan. 15, 2015 — Novogen Limited (ASX:NRT; NASDAQ:NVGN), an Australian/US biotechnology company, today announced an important discovery in its regenerative medicine program that has delivered a key proof-of-concept step forward in the quest to develop drugs capable of stimulating the function of brain tissue stem cells.
Regenerative medicine is concerned with repairing or replacing tissue lost due to age, disease, damage or congenital defects. In the case of the brain, damage associated with stroke, head trauma or neurodegenerative disease represents a very significant unmet clinical need for such therapies.
Novogen scientists now in an important scientific breakthrough have identified a family of compounds with an ability to promote the growth and activity of normal brain stem cells.
The dominant approach being taken to brain regeneration is the introduction of tissue stem cells that have been cultured outside of the body. However, delivery of these cells through the skull is very invasive and, so far, these cells seem to be susceptible to the same constraints that limit the resident stem cell population.
Work in the 1990’s showed that the old adage, ‘We continue to grow brain cells until age 21, and from then on it’s all downhill’, was, in fact, untrue. Close examination revealed that part of the hippocampus, the main site of learning and memory within the brain, is constantly renewed throughout life by a pool of dividing stem cells. A second discrete pool of stem cells generates daughter cells that can migrate to sites of brain damage to facilitate repair. Unfortunately, for reasons that are not currently understood, these migrating stem cells fail to produce enough new neurons in the damage site to provide substantial recovery.
Novogen adopted the alternative approach of seeking drugs that would promote the migration of stem cells to the site of injury, seek to retain those stem cells at the damaged site, and then promote their regenerative capacities. This offered the potential of a non-invasive, well-tolerated, medicinal approach to a widespread problem.
In April 2014, Novogen established a partnership with Genea Biocells, an Australian company with world-leading expertise in the production, growth and development of human embryonic stem cells. The original purpose of that collaboration was to mine the Company’s super-benzopyran drug technology platform for new therapies with the capacity to repair aberrant stem cells in people with various neurodegenerative and musculedegenerative disorders such as muscular dystrophies and motor neurone diseases.
That program recently was extended to look at the ability of that same drug platform to stimulate the growth of healthy brain stem cells to create new nerve cells. That has been achieved in what is the first key step in the path to the development of a new family of drugs to treat brain injury.
About Novogen Limited
Novogen is a public, Australian drug-development company whose shares trade on both the Australian Securities Exchange (‘NRT’) and NASDAQ (‘NVGN’). The Novogen group includes US-based, CanTx Inc, a joint venture company with Yale University.
Novogen has two main drug technology platforms: super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP compounds have been designed to kill the full heterogeneity of cells within a tumor, including the cancer stem cells. The molecular target is a trans-membrane electron-transfer pump mechanism oncogene that is common to all cancer cells. Cells die by respiratory distress and mitochondrial disintegration.
The ATM compounds target the micro-filament component of the cancer cell’s cytoskeleton and have been designed to combine with anti-microtubular drugs (taxanes, vinca alkaloids) to produce comprehensive and fatal destruction of the cancer cell cytoskeleton.
The Company pipeline comprises three SBP drug candidates (TRXE-002, TRXE-009, TRXE-0025) and one ATM drug candidate (‘Anisina’).
Further information is available on our websites www.novogen.com
For more information please contact:
Corporate Contact | Media Enquiries |
Dr. Graham Kelly | Cristyn Humphreys |
Executive Chairman & CEO Novogen Group | Chief Operating Officer Novogen Group |
Graham.Kelly@novogen.com | Cristyn.Humphreys@novogen.com |
+61 (0) 2 9472 4100 | +61 (0) 2 9472 4111 |
(LODE) Licenses Mineral Rights for the HOPE Gold Coin
With Five Metric Tons of Validated Measured and Indicated Resources
VIRGINIA CITY, NV–(January 15, 2015) – Comstock Mining Inc. (“Comstock Mining” or “Comstock”) (NYSE MKT: LODE) a producing, gold and silver mining company, based in Nevada’s historic Comstock Lode District and representing more than 150 years of mining history and mining innovation, has agreed to license an initial five metric tons of gold (or gold-equivalent) of validated, measured, and indicated resources to support the value of the initial 50 Million HOPE Gold Coins being sold. The HOPE Gold Coin is a new cryptographic currency being launched by the HOPE Gold Coin Charitable Trust (the “HOPE Charitable Trust”). Ultimately, the maximum number of HOPE Gold Coins in circulation will be supported by 100 metric tons of physical gold bullion, preferably from Comstock, purchased and directly owned by the HOPE Charitable Trust.
Proceeds from the sale of HOPE Gold Coins will be expressly used by the HOPE Charitable Trust to support charitable, aid and other humanitarian causes worldwide. By purchasing HOPE Gold Coins, buyers are directly helping others while acquiring a valuable asset that can also be donated or used for other worthy purposes, effectively increasing the benefit to charities or others.
“Philosophically, we believe that gold is the ideal asset for this purpose because of its universal acceptance as a precious metal store of value and its strong historical association with currencies around the world. Initially, we prefer using gold resources as it represents the safest, most efficient and environmentally friendly approach, plus there seems no safer vault than the earth itself.” – Peter Hsu, a member of the Protector Committee of the HOPE Gold Coin Charitable Trust.
Comstock Mining is a socially responsible, actively producing gold and silver mining company that is simultaneously advancing both its environmental and economic objectives. Comstock’s philosophies are fully aligned with the HOPE Charitable Trust’s philanthropic mission and purpose. The Comstock Lode has a long and profound association with technological, monetary and industry innovations dating back over 150 years.
Corrado De Gasperis, President and CEO of Comstock Mining Inc., stated: “HOPE Charitable Trust is an exceptional opportunity for us to safely and responsibly enhance revenue, support a charitable endeavor of the highest purpose, and sustain Comstock innovations that define our brand. We are extremely selective with our strategic alliances and the Comstock brand and proud to partner with this exceptional organization.”
The gold and silver produced by Comstock is responsibly mined with reclamation and restoration standards, far exceeding minimum compliance requirements. Comstock Mining has an internal policy as well as a legal commitment to practice concurrent reclamation as part of its on-going operations. The company is committed to full preservation and restoration of historic structures either directly or through its support of the Comstock Foundation for History and Culture.
Comstock Mining owns or controls over 8,000 acres in the Comstock Historic District, a 14,000-acre historic, world-class mining district that includes the Comstock Lode, one of the world’s richest and most important gold and silver discoveries, having produced over 8 million ounces of gold and over 192 million ounces of silver.
This press release is neither an offer to sell nor a solicitation of an offer to buy any securities in the United States or elsewhere.
About Comstock Mining Inc.
Comstock Mining Inc. is a producing, Nevada-based, gold and silver mining company. The company has extensive, contiguous property in the historic Comstock and Silver City mining districts and adheres to socially conscious and environmentally sustainable mining practices. Because of the Comstock District’s historic significance and its historic, world-class bonanza precious metal grades, the geology is well known and has been extensively studied by global industry, academic and regulatory experts.
About the HOPE Gold Coin Charitable Trust
The HOPE Gold Coin Charitable Trust is a charitable trust under UK law with built-in checks-and-balances designed to ensure its management and operational integrity and transparency. The Charitable Trust was expressly established to undertake the development, production, sale and management of the HOPE Gold Coin as well as to ensure that proceeds from the sale of HOPE Gold Coins will be used for charitable causes and activities.
www.comstockmining.com / www.hopegoldcointrust.org / www.hopegoldcoin.org
Cautionary Note
The HOPE Gold Coin was created and is administered by The HOPE Gold Coin Charitable Trust (the “Charitable Trust”). All proceeds derived from the HOPE Gold Coin will be solely used by the Charitable Trust to support philanthropic and charitable activities. The HOPE Gold Coin is a cryptographic currency created by the Charitable Trust. To support the value of the HOPE Gold Coin, the Charitable Trust has entered agreements to license mineral resources residing in the ground that are validated according to industry standards, but not physical gold.
The estimated quantities and amount of mineral resource licensed for each HOPE Gold Coin is equal to the value of 1/10th of one gram of gold or gold equivalent.
The mineral resources licensed are categorized according to industry standards as inferred, indicated and/or measured mineral resources that may or may not be a probable or proven reserve. Factors preventing inferred, indicated and/or measured mineral resources from also being designated a probable or proven reserve include economically unfeasible high extraction and processing cost and/or the lack of required permits.
The Charitable Trust chose gold as the commodity to be licensed because of its recognized value as well as historic association with and/or use as a medium of exchange. Mineral resources believed to contain gold and silver were chosen for security and for equally important environmental reasons. There is no better vault on earth than the earth itself and coincidentally preserves land for other use.
IMPORTANT
The purchase, ownership and/or use of HOPE Gold Coins does not in any way or form imply, infer or in any way grant or entitle the purchaser, owner and/or user any interest in or ownership of any mineral resource licensed. The HOPE Gold Coin cannot be redeemed or exchanged for any real, physical gold or any other precious metal.
THE HOPE GOLD COINS ARE NEITHER INTERESTS IN NOR THE RESPONSIBILITIES OR OBLIGATIONS OF ANY MINING COMPANY LICENSING MINERAL RESOURCES TO THE HOPE GOLD COIN CHARITABLE TRUST AND/OR, ANY OF THEIR SUBSIDIARIES, AFFILIATES OR ANY OF THEIR ASSETS, AND ARE NOT REDEEMABLE OR OTHERWISE EXCHANGEABLE FOR GOLD, SILVER OR ANY OTHER REAL PROPERTY, PERSONAL PROPERTY OR INTELLECTUAL PROPERTY OF ANY MINING COMPANY. MEASURED, INDICATED and INFERRED GOLD-EQUIVALENT RESOURCES ARE NOT EQUIVALENT TO GOLD OR SILVER RESERVES.
Contact Information
Corrado De Gasperis
President & CEO
Comstock Mining Inc.
degasperis@comstockmining.com
+1.775.847.4755
Peter Hsu
Protector
HOPE Gold Coin Charitable Trust
peter.h@hopegoldcointrust.org
+1.312.929.2229
(KONE) FY 2014 FInancials, FY 2015 Guidance
FY14 Revenues Decreased 46.5% to $6.2 million from $11.6 million in the Prior Year FY14 Gross Profit Increased 92.0% to $2.0 million from $1.0 million in the Prior Year FY14 Basic and Diluted Loss Per Share Up to $0 from Loss Per Share of $3.65 in the Prior Year
XI’AN, China, Jan. 15, 2015 — Kingtone Wirelessinfo Solution Holding Ltd (Nasdaq CM: KONE) (“Kingtone”, or the “Company”), a China-based developer and provider of mobile enterprise solutions, today announced financial results for its fiscal year ended September 30, 2014. The financial statements and other financial information included in this press release are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
Fiscal Year 2014 Financial Highlights
- Revenues decreased by 46.5% to approximately $6.2 million from approximately $11.6 million in the prior year period.
- Gross profit increased by 92.9% to approximately $2.0 million gross profit from approximately $1.0 million loss in the prior year period.
- Gross margin increased to 31.7% from 8.8% in the prior year period.
- Net loss of approximately $1 thousand as compared to net loss of approximately $5.1 million in the prior year period.
- Basic and diluted loss per share were $0 as compared to loss per share of $3.65 in the prior year period with weighted average shares outstanding of 1,405,000 in both periods.
“We are pleased with our cost-control process leading our significantly increased profit during the last fiscal year,” said Mr. Peng Zhang, Chief Executive Officer of the Company, “Looking forward to the Fiscal Year 2015, we expect revenue of $12.0 million to $15.0 million; net income of $0.5 million to $1.0 million. We are confident in accomplishing our goals in the next year.”
Fiscal Year 2014 Financial Performance
Results of Operations – The fiscal year ended September 30, 2014 compared to the fiscal year ended September 30, 2013.
Revenue
We are a China-based developer and provider of mobile enterprise solutions. We generate revenue in two ways, from customized software middleware and applications for various public and private service agencies, which we identify as software solution sales, and from packaged solutions that include both software and hardware in automation telematics for clients mainly in the manufacturing sector, which we identify as wireless system solution sales. In the year ended September 30, 2014, we experienced a significant contraction in our software solution business and our wireless system solution business. Thereafter our revenue decreased by 46.5% to approximately $6.2 million in the year ended September 30, 2014 from approximately $11.6 million in the year ended September 30, 2013.
Our revenue from software solution sales decreased by 35.7% to approximately $0.2 million in the year ended September 30, 2014 from approximately $0.3 million in the year ended September 30, 2013. As a percentage of total revenue, software solution sales increased from 2.5% to 3.0%.
Our revenue from wireless system solution sales decreased by 46.8% to approximately $6.0 million in the year ended September 30, 2014 from approximately $11.3 million in the year ended September 30, 2013. As a percentage of total revenue, wireless system solution revenue decreased from 97.5% to 97.0% of our total revenue. This decreased was insignificant.
Cost of Sales
Our cost of sales decreased by 60.0% to approximately $4.2 million in the year ended September 30, 2014 from approximately $10.5 million in the year ended September 30, 2013. The decrease in cost of sales was primarily attributable to the decrease in revenue and increase in gross margin from both of our business sections. As a percentage of our total revenues, our cost of sales decreased to 68.3% of revenues in the year ended September 30, 2014 from 91.2% of our total revenues in the year ended September 30, 2013, which is partially attributable to the fact that the projects the Company had worked on were with old clients and therefore made our work more efficient.
Cost of sales for software decreased by 81.9% to approximately $0.1 million in the year ended September 30, 2014 from approximately $0.5 million in the year ended September 30, 2013, representing 2.5% and 5.4% of our total cost of sales and 55.1% and 195.2% of our software revenue in the fiscal years ended September 30, 2014 and 2013, respectively. Cost of sales for wireless system solutions decreased by 58.7% to approximately $4.1 million in the year ended September 30, 2014 from approximately $10.0 million in the year ended September 30, 2013, representing 97.5% and 94.6% of total cost of sales and 68.7% and 88.5% of wireless system solution revenues in the fiscal years ended September 2014 and 2013, respectively. The decreased percentage of cost of sales in our both business sections from September 30, 2013 to September 30, 2014 was mainly due to the decrease in revenue and increase in gross margin.
Gross Profit and Gross Margin
Our total gross profit increased by 92.9% to approximately $1.96 million gross profit in the year ended September 30, 2014 from approximately $1.02 million loss in the year ended September 30, 2013. Our total gross margin was 31.7% and 8.8% in the years ended September 30, 2014 and 2013 of total revenue, respectively. This increase of gross profit and gross margin was primarily due to the increase in industry profit and profit margin and revenue from Jingbian integration project that was partially recognized in the last fiscal year as of September 30, 2014.
Our gross profit for software solution sales increased by 69.7% to approximately $0.08 million in the year ended September 30, 2014 from approximately $0.3 million loss in the year ended September 30, 2013. Our gross margin for software solutions sales increased to 44.9% in the year ended September 30, 2014 from minus 95.2% in the year ended September 30, 2013. Our gross profit for wireless system solution sales increased by 45.2% to approximately $1.9 million in the year ended September 30, 2014 from approximately $1.3 million in the year ended September 30, 2013. Our gross margin for wireless system solution sales increased to 31.3% in the year ended September 30, 2014 from 11.5% in the year ended September 30, 2013, which is partially attributable to the higher margin of some of the wireless projects. The increase in gross margins in both of our business sections above was due to the fact we had higher gross margin projects and smaller up-front investments with old customers comparing to the last fiscal year.
Loss from Operations
We incurred a loss of $0.5 million in the year ended September 30, 2014, a 79.1% decrease in such a loss from approximately loss of $2.6 million in the year ended September 30, 2013. The decrease in loss from operations was mainly due to significantly higher gross profit from wireless system solutions business compounded by decreased operating expenses.
Other Income (Expense)
Our other income increased 143.3% to approximately $0.5 million in fiscal year 2014 from approximately $1.2 million of other expense in fiscal year 2013, and represented 8.2% and 10.2% of our revenue for the years ended September 30, 2014 and 2013, respectively. The increase in our other income was largely due to our rental income. In April 2008, we purchased an approximately 20,000 square meter six-story warehouse and industrial facility in Xi’an, which we named the “Kingtone Center”. On October 28, 2013, the Company signed a twenty-year lease agreement with Xi’an Zhongde Orthopedics Hospital Co., Ltd. (“Zhongde”). According the lease agreement, the Company shall lease “Kingtone Center” to Zhongde with a monthly rent of approximately $0.1 million from July 1, 2014 till December 31, 2034. The rent will have an incremental 2 percent increase year over year during the next following years.
As a US listed company, the Company is in need of US dollar to cover oversea expenses. Since State Administration of Foreign Exchange in China imposes restrictions on the remittance of currency out of China, Topsky and Kingtone Information entered into a loan and guarantee agreement on July 21, 2011 with an unrelated third party to have Topsky borrow US$3 million to cover oversea expenses and take RMB27.9 million, or US$4.2 million from Kingtone Information as a guarantee. The offset amount US$1.2 million was presented as long-term other receivables in the anticipation that the agreement would be settled in two years. The loan matured on July 21, 2013 and the long-term receivable was non-collectable. As a result, we have written off the balance of the long-term receivable and charged to other expensed for the year ended September 30, 2013.
Net Loss
We incurred a net loss of $0.001 million in the year ended September 30, 2014 as compared to net loss of approximately $5.1 million in the year ended September 30, 2013, representing a decrease of 99.9% in net loss. Basic and diluted loss per share was $0 in the year ended September 30, 2014, compared to loss per share $3.65 in the prior year period. The number of weighted average ordinary shares outstanding was 1,405,000 for the years ended September 30, 2014 and 2013, respectively.
Liquidity and Capital Resources.
Cash and Cash Equivalents.
As of September 30, 2014, the Company had cash and cash equivalents of $6.1 million, compared to $6.4 million in the prior year period.
Net cash used in operating activities was approximately $0.3 million for the year ended September 30, 2014 as compared to $0.4 million net cash used in operating activities for the year ended September 30, 2013. During 2014, the Company had a net loss of $1,000 and depreciation and amortization of $0.6 million. In addition, the Company had decreased accounts and notes receivable by $0.3 million and decreased unbilled revenue by $1.0 million.
Net cash used in investing activities for the year ended September 30, 2014 was approximately $137,000 as compared to net cash provided by investing activities of approximately $7,000 for the year ended September 30, 2013. The cash used in investing activities in 2014 was mainly due to purchasing certain property and equipment. The cash provided by investing activities in 2013 was mainly a result of the sale of certain property and equipment.
Net cash used in financing activities for the year ended September 30, 2014 was approximately $2.1 million as compared to net cash used in financing activities of approximately $0.02 million for the year ended September 30,2013.The cash used in financing activities was mainly due to the loan to related parities.
Financial Outlook.
For the fiscal year ending September 30, 2015, management expects revenues of $12.0 million to $15.0 million and net income of $0.5 million to $1.0 million.
Conference Call
The Company hosted a conference call to discuss its fiscal year 2014 financial results at 8:00 a.m. ET on Thursday, January 15, 2015. Mr. Tao Li, Chairman, Mr. Peng Zhang, Chief Executive Officer, Ms. Li Wu, Chief Financial Officer and Mr. Fang Wang, Assistant to the Chief Financial Officer, were on the call.
To participate in the conference call, please dial any of the following numbers:
USA Toll Free: | 877-407-9205 |
International: | 201-689-8054 |
Conference | ID #: 13598549 |
A replay of the call will be available until 11:59 PM ET on Jan. 17, 2014.
To access the replay, please dial any of the following numbers:
USA Toll Free: | 877-660-6853 |
International: | 201-612-7415 |
The conference call was webcast live by Vcall and can be accessed at http://www.investorcalendar.com/IC/CEPage.asp?ID=173506.
About Kingtone Wirelessinfo Solution Holding Ltd
Kingtone Wirelessinfo Solution Holding Ltd (Nasdaq CM: KONE) is a China-based developer and provider of mobile enterprise solutions. The Company’s products, known as mobile enterprise solutions, extend a company’s or enterprise’s information technology systems to include mobile participants. The Company develops and implements mobile enterprise solutions for customers in a broad variety of sectors and industries, to improve efficiencies by enabling information management in wireless environments. At the core of its many diverse packaged solutions is proprietary middleware that enables wireless interactivity across many protocols, devices and platforms.
For more information, please visit Kingtone’s website at http://en.kingtoneinfo.com/. The Company routinely posts important information on its website.
Safe Harbor Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including certain plans, expectations, goals, and projections, which are subject to numerous assumptions, risks, and uncertainties. These forward-looking statements may include, but are not limited to, statements containing words such as “may,” “could,” “would,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “expects,” “intends”, “future” and “guidance” or similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to change at any time. These forward-looking statements are based upon management’s current expectations and are subject to a number of risks, uncertainties and contingencies, many of which are beyond the Company’s control that may cause actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. The Company’s actual results could differ materially from those contained in the forward-looking statements due to a number of factors, including those described under the heading “Risk Factors” in the Company’s Annual Report for the fiscal year ended September 30, 2013 filed with the Securities and Exchange Commission. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required under applicable law.
For investor and media inquiries, please contact:
Mr: Fang Wang
Tel: +86-29-8826-6383
Email: wangfang@kingtoneinfo.com
(NETE) to Present at Noble Financial Capital Markets 11th Annual Equity Conference
CEO Oleg Firer to discuss Net Element’s leading position in fast-growing mobile payments market
MIAMI, Jan. 15, 2015 — Net Element, Inc. (NETE) (“the Company”), a technology-driven group specializing in mobile payments and value-added transactional services in emerging countries and in the United States, today announced that its Chief Executive Officer, Oleg Firer, will present at the upcoming Noble Financial Capital Markets 11th Annual Equity Conference taking place at the Club Med in Sandpiper Bay, Florida, from January 18-21, 2015.
The presentation by Net Element Chief Executive Officer Oleg Firer is scheduled for Tuesday, January 20th at 2:00 p.m. Eastern Standard Time in Room 4, and will include an overview of the company’s products, services and operations, as well as its position in the mobile payments market.
A “live” audio and high-definition video webcast of Net Element’s presentation, along with a copy of the presentation materials, will be available online at:
http://noble.mediasite.com/mediasite/Play/d238b329619e4fe8ae9e78bbca222d071d.
Those wishing to access to the video webcast need to register at least 10 minutes prior to the start of the presentation.
Investors interested in arranging one-on-one meetings with management should contact Noble Financial Group.
About Noble Financial Capital Markets
Noble Financial Capital Markets was established in 1984, and 2015 marks the company’s 31st Anniversary. Noble Financial is a research-driven boutique investment bank focused on emerging growth companies. The company has offices in Boston, Los Angeles, and Boca Raton, Florida. In addition to non-deal road shows and sector-specific conferences throughout the year, Noble Financial hosts its large-format annual equity conference in January in South Florida featuring 120 to 150 presenting companies from across North America and a total attendance of close to 600. For more information, please visit www.noblefcm.com.
About Net Element
Net Element (NASDAQ: NETE) is a global technology-driven group specializing in mobile payments and value-added transactional services. The Company owns and operates a global mobile payments and transaction processing provider, TOT Group. TOT Group companies include Unified Payments, recognized by Inc. Magazine as the #1 Fastest Growing Private Company in America in 2012; Aptito, a next generation cloud-based point of sale payments platform; and TOT Money, which has been ranked as the #1 SMS content provider by Russia’s second largest telecommunications operator. Together with its subsidiaries, Net Element enables ecommerce and adds value to mobile commerce environments. Its global development centers and high-level business relationships in the United States, Russia and Commonwealth of Independent States strategically position the Company for continued growth. Net Element has U.S. headquarters in Miami and offices in Moscow. More information is available at www.netelement.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether Net Element or its business continues to grow and whether the financing secured by Net Element will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element ‘s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element ‘s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element ‘s ability to successfully expand in existing markets and enter new markets; (iv) Net Element ‘s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element ‘s business; (viii) changes in government licensing and regulation that may adversely affect Net Element ‘s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element ‘s business; (x) Net Element ‘s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk that the U.S. government may decide to impose further sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
(QURE) uniQure Collaboration to Develop a Gene Therapy for ALS
ROTTERDAM, the Netherlands, January 14, 2015 —
Treeway B.V., founded by entrepreneurs Bernard Muller and Robbert Jan Stuit, both diagnosed with ALS, have announced a collaboration with uniQure N.V., a leading gene therapy company, (NASDAQ:QURE), to develop a gene therapy treatment for ALS.
Under the terms of the licensing and collaboration agreement, uniQure has granted Treeway an exclusive license in this field to uniQure’s relevant AAV5 viral vector and GDNF (Glial cell-derived neurotrophic factor) intellectual property. Treeway is responsible for the preclinical and clinical development of the ALS gene therapy treatment. uniQure will provide Treeway with its manufacturing capabilities and will further collaborate with Treeway on ALS gene therapy development. Treeway and uniQure will jointly commercialize any resulting ALS gene therapy with defined geographical rights for commercialization assigned to each company. Financial details of the agreement have not been disclosed.
Inez de Greef, CEO of Treeway, is very pleased about this licensing, collaboration, and co-marketing agreement as it represents a major milestone in executing its mission to develop ALS therapy. “Gene therapy is an innovative and viable technology for developing an ALS therapy and has the potential to change the disease course of ALS. A collaboration between Treeway and uniQure will accelerate this development by bringing two unique companies together,” says Ms. de Greef.
Jörn Aldag, CEO of uniQure, adds: “We are impressed by the immense energy and will power of the Treeway founders in seeking a cure for ALS. We believe that by combining their disease know-how and uniQure’s gene therapy platform and expertise, we can jointly achieve a step forward in the way ALS is treated in the future.”
Note for the editor
about ALS
Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s disease, is a relentless progressive neurodegenerative disease that causes muscle weakness, disability and eventually death, with a median survival of three years. To date, there is no cure for ALS.
uniQure
uniQure is delivering on the promise of gene therapy, single treatments with potentially curative results. We have developed a modular platform to rapidly bring new disease modifying therapies to patients with severe disorders. Our approach is validated by multiple partnerships and the regulatory approval of our lead product Glybera. http://www.uniQure.com
Treeway B.V.
Treeway is a biotechnology company and has been founded by entrepreneurs Bernard Muller and Robbert Jan Stuit, both diagnosed with ALS. Treeway’s strategy is founded on a cohesive combination of approaches that together should provide the highest likelihood of bringing successful treatments for ALS to the patient in the short term.
For questions and more information about Treeway, please contact via Inez de Greef info@treeway.nl or http://www.treeway.nl / +31-10-298-88-88.
(NLST) Court Throws Out Diablo’s Countersuit Against Netlist
Federal Court Orders Diablo to Pay Netlist Attorneys’ Fees and Costs Netlist Wins Another Legal Victory in Trade Secret, Breach of Contract Lawsuit Against Diablo Technologies, Inc. in Case Involving ULLtraDIMM SSD
OAKLAND, Calif., Jan. 14, 2015 — Netlist, Inc. (NASDAQ: NLST) announced today that Judge Yvonne Gonzalez Rogers of the United States District Court for the Northern District of California granted Netlist’s Special Motion to Strike Diablo’s claims against Netlist for breach of contract, unfair competition, and interference with Diablo’s customers. The Court also ruled that Netlist is entitled to reasonable attorneys’ fees and costs associated with Netlist’s filing of the Special Motion to Strike.
With all of its claims having now been stricken, Diablo has no affirmative claims to pursue in the trade secret lawsuit while Netlist’s claims for misappropriation and breach of contract remain intact as the March 9, 2014 trial date approaches. Under the Court’s order issued January 12, Judge Gonzales Rogers found that Netlist’s actions, including filing the trade secret law suit and discussing the suit with customers, fell squarely within California statutes designed to protect constitutional free speech and statements related to litigation. One of these statutes allows for early dismissal of meritless claims aimed at chilling protected speech, so as to avoid costly, time-consuming litigation.
“We are pleased that the court acted quickly in striking Diablo’s frivolous claims”, said C.K. Hong, Netlist’s Chief Executive Officer. “We remained confident throughout that Diablo’s claims would not survive legal scrutiny. Thankfully, neither we nor the court will be forced to waste any more resources on Diablo’s claims, and Diablo will cover the expenses we incurred to bring this to the court’s attention.”
This ruling came on the heels of Judge Gonzalez Rogers taking the rare step of ordering a preliminary injunction against Diablo from manufacturing, using, distributing or selling high-speed memory chips used by SanDisk and other major computer manufacturers.
About Netlist:
Netlist, Inc. designs and manufactures high-performance, logic-based memory subsystems for server and storage applications for cloud computing. Netlist’s flagship products include NVvault™ and EXPRESSvault™ family of hybrid memory products that significantly accelerate system performance and provide mission critical fault tolerance, HyperCloud®, a patented memory technology that breaks traditional performance barriers, and a broad portfolio of industrial Flash and specialty memory subsystems including VLP (very low profile) DIMMs and Planar-X RDIMMs. Netlist has steadily invested in and grown its worldwide IP portfolio, which now includes 81 issued and pending patents in the areas of high performance memory and hybrid memory technologies.
Netlist develops technology solutions for customer applications in which high-speed, high-capacity, small form factor and efficient heat dissipation are key requirements for system memory. These customers include OEMs and hyperscale datacenter operators that design and build servers, storage systems and high-performance computing clusters, engineering workstations and telecommunications equipment. Founded in 2000, Netlist is headquartered in Irvine, CA with manufacturing facilities in Suzhou, People’s Republic of China. Learn more at www.netlist.com.
Safe Harbor Statement:
This news release contains forward-looking statements regarding future events and the future performance of Netlist. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expected or projected. These risks and uncertainties include, but are not limited to, risks associated with the launch and commercial success of our products, programs and technologies; the success of product partnerships; continuing development, qualification and volume production of EXPRESSvault™, NVvault™, HyperCloud® and VLP Planar-X RDIMM; the timing and magnitude of the anticipated decrease in sales to our key customer; our ability to leverage our NVvault™ technology in a more diverse customer base; the rapidly-changing nature of technology; risks associated with intellectual property, including patent infringement litigation against us as well as the costs and unpredictability of litigation over infringement of our intellectual property and the possibility of our patents being reexamined by the United States Patent and Trademark office; volatility in the pricing of DRAM ICs and NAND; changes in and uncertainty of customer acceptance of, and demand for, our existing products and products under development, including uncertainty of and/or delays in product orders and product qualifications; delays in the Company’s and its customers’ product releases and development; introductions of new products by competitors; changes in end-user demand for technology solutions; the Company’s ability to attract and retain skilled personnel; the Company’s reliance on suppliers of critical components and vendors in the supply chain; fluctuations in the market price of critical components; evolving industry standards; and the political and regulatory environment in the People’s Republic of China. Other risks and uncertainties are described in the Company’s annual report on Form 10-K filed on March 18, 2014, and subsequent filings with the U.S. Securities and Exchange Commission made by the Company from time to time. Except as required by law, Netlist undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(NRX) to Present at the Noble Financial Capital Markets Equity Conference
NephroGenex, Inc. (Nasdaq:NRX), a pharmaceutical company focused on the development of therapeutics to treat kidney disease, today announced that Chief Executive Officer, Pierre Legault will present a corporate overview of the Company at the Noble Financial Capital Markets Eleventh Annual Equity Conference in Sandpiper, Florida.
The presentation will take place on Tuesday, January 20th at 10:30 am EST.
Live and archived webcasts of the presentation will be accessible from the Company’s website at http://nephrogenex.investorhq.businesswire.com/events-calendar. A replay will be available for 30 days following the event.
In the presentation, Mr. Legault will review the Company’s Pyridorin program for the treatment of diabetic nephropathy, a chronic, degenerative disease of the kidney affecting approximately 6 million patients in the U.S. for whom there are few therapeutic options. The Company launched its Phase 3 trial with Pyridorin in the second quarter of 2014.
Mr. Legault will also attend the 28th Annual Private Placements Industry Forum in Miami, Florida on January 27-29 where he will conduct a series of one-on-one meetings with investors.
About NephroGenex, Inc.
NephroGenex (Nasdaq:NRX) is a clinical-stage pharmaceutical company focused on developing therapeutics to treat kidney diseases caused by pathogenic oxidative chemistries. Since our inception, we have collaborated with the leading scientific experts in pathogenic oxidative chemistries to build a strong portfolio of intellectual property and novel acting drug candidates. Our clinical program has been done in collaboration with world leading clinical investigators in kidney disease. Our product pipeline includes an oral formulation of Pyridorin, which is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy, as well as an intravenous formulation of Pyridorin to treat specific types of acute kidney injury.
Cautionary Note on Forward-Looking Statements
This press release contains certain statements that are, or may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning and include, but are not limited to, statements regarding the outlook for our future business and financial performance. Forward-looking statements are based on our current expectations and assumptions, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may differ materially from those in the forward-looking statements due to global political, economic, business, competitive, market, regulatory and other factors and risks, including the items identified under “Part I—Item 1A—Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2013, filed with the Securities and Exchange Commission (“SEC”) on March 31, 2014, as well as in other filings that we may make with the SEC in the future. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements.
Investors:
The Trout Group
Michael Levitan, 646-378-2920
mlevitan@troutgroup.com
or
Media:
BMC Communications
Susan Duffy, 646-513-3119
sduffy@bmccommunications.com
(RGDO) and Tobira Therapeutics Announce Merger Agreement
Closing Cash Balance of Approximately $60 Million Provides Financing Through Phase 2b NASH Program Conference Call Scheduled for Tuesday, Jan. 20, 8:30 a.m. EST
SAN FRANCISCO and BASKING RIDGE, N.J., Jan. 14, 2015 — Regado Biosciences, Inc. (NASDAQ: RGDO) and Tobira Therapeutics, Inc. today announced that they have entered into a definitive agreement under which privately-held Tobira will merge with a wholly-owned subsidiary of Regado in an all-stock transaction. The merger will create a company focused on the development of novel treatments for liver and inflammatory diseases. Tobira’s lead product, immunomodulator and anti-fibrotic agent cenicriviroc (CVC), received Fast Track Designation and is currently in a Phase 2b trial in non-alcoholic steatohepatitis (NASH). Upon closing of the transaction, Regado will be renamed Tobira Therapeutics, Inc., and will be under the leadership of Tobira’s chief executive officer, Laurent Fischer, M.D.
A Tobira investor syndicate has committed to invest up to $22 million in the combined company. This financing is expected to fully fund the CVC development program through the completion of the Phase 2b program. The financing is expected to close before or concurrently with the completion of the merger with Leerink Partners and Oppenheimer & Co. expected to act as financial advisors. All of Tobira’s preferred stock investors, including Domain Associates, Novo Ventures, Frazier Healthcare, Montreux Equity Partners and Canaan Partners, have committed to participate in the financing. Total cash balance of the combined company following the closing of the merger and the financing is expected to be approximately $60 million.
“Following an extensive and thorough review of strategic alternatives, we believe the proposed merger with Tobira provides the opportunity for substantial returns for Regado shareholders,” said Michael A. Metzger, Regado’s president and chief executive officer. “We expect Tobira to be the next breakout company in NASH based on the best-in-class profile and potential of their lead drug CVC. The merged company will derive a significant advantage from the extensive clinical, commercial and transactional expertise of the combined board and management teams. We are optimistic that the strength of the leadership team, coupled with the cash Regado will contribute to the merger, will enable CVC to reach significant value inflections in the near term.”
Laurent Fischer, M.D., chairman and chief executive officer of Tobira, said, “The merger and concurrent financing will allow the company to fully fund Tobira’s ongoing Phase 2b CENTAUR study of CVC in patients with NASH and liver fibrosis. We expect to have top line data from the study in the second quarter of 2016. In addition, the strong closing balance sheet allows us to expand our NASH program with additional studies of CVC in non-alcoholic fatty liver disease and combination settings that will help position CVC as a cornerstone therapy for this troubling complication of the ongoing obesity epidemic.”
CVC is a first-in-class immunomodulator and the only compound in development for NASH that targets inflammation and fibrosis. CVC has been evaluated in approximately 580 subjects across clinical programs. CVC is being evaluated in patients with NASH for its potential to reduce liver inflammation and slow down or reverse progression of liver fibrosis or progression to cirrhosis.
The CENTAUR study is a randomized, double-blind Phase 2b study of a single 150 mg tablet of CVC given once daily versus placebo in patients with NASH and liver fibrosis. CENTAUR is an international study with planned treatment centers across North America, Europe, Hong Kong and Australia. The study will enroll approximately 250 patients and will evaluate the non-alcoholic fatty liver disease (NAFLD) activity score (NAS) and resolution of NASH without worsening of liver fibrosis after one and two years of treatment as compared to placebo. These endpoints are aligned with findings and recommendations from an American Association for the Study of Liver Diseases (AASLD) – FDA joint workshop that identified potentially acceptable surrogate endpoints for clinical studies of agents for NASH and liver fibrosis, a disease for which no treatments are approved.
Details of the Proposed Transaction
On a pro forma basis and based upon the number of shares of Regado common stock to be issued in the merger, current Regado shareholders will own approximately 32% of the combined company and current Tobira shareholders will own approximately 68% of the combined company (determined before accounting for the financing transaction discussed above). The actual allocation will be subject to adjustment based on Regado’s net cash balance. The transaction has been approved by the board of directors of both companies. The merger is expected to close in the second quarter of 2015, subject to the approval of the stockholders of each company as well as other customary conditions.
MTS Health Partners, L.P., and Cowen and Company, LLC, served as financial advisors, and Cooley LLP served as legal counsel to Regado and Gunderson Dettmer LLP served as legal counsel to Tobira with respect to the transaction.
Management and Organization
Following the merger, the company will be led by Dr. Fischer as chief executive officer. The board of directors of the combined company will be comprised of nine representatives, three of whom will be designated by Regado and the remaining six of whom will be designated by Tobira. Dennis Podlesak, current chairman of Regado’s board, will be chairman of the board of the combined company. The corporate headquarters will be located in South San Francisco, California.
Conference Call
Interested participants and investors may access the conference call by dialing (888) 347-1165 for domestic callers or (412) 902-4276 for international callers. The conference call will be webcast live under the investor relations section of the Regado website at www.regadobio.com and will be archived there for 60 days following the call.
About Cenicriviroc & NASH
Cenicriviroc (CVC) is an oral, once daily, first-in-class dual CCR2/CCR5 antagonist with implications in fibrosis and HIV-1. Both the CCR2 and CCR5 pathways play a key role in the cycle of inflammation and fibrosis and CVC has been shown in clinical trials to bind to both CCR2 and CCR5 targets. CVC’s safety and tolerability profile has been evaluated in approximately 580 subjects who have been dosed in Phase 1 and Phase 2 trials, including 115 HIV-1 infected subjects on treatment for up to 48 weeks. NASH is a disease that affects three to five percent of the U.S. population and can lead to liver cirrhosis and liver cancer. Currently there are no approved treatments for NASH. Tobira believes CVC has the potential to play a differentiated role in the management of this chronic disease and expects the eventual management of NASH will include multi-targeted combination treatment approaches, much the same as HIV-1 is treated today.
About Regado Biosciences
Regado Biosciences, Inc. is a development stage biotechnology company that was engaged in the development of therapies using actively controlled aptamer technology, which is designed to give physicians the ability to control the therapeutic effect in real time. In August, 2014, the Company announced the termination of its Phase 3 REGULATE-PCI study due to safety concerns with its lead drug Revolixys. The Company subsequently announced the planned reorganization of its business and the pursuit of strategic alternatives led by its financial advisors MTS Health Partners and Cowen and Company, LLC. No further development activities are ongoing nor have any been planned for the Regado pipeline. The final results of the REGULATE-PCI study will be presented at one or more upcoming medical meetings in the first half of 2015. More information can be found at www.regadobio.com.
About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV. The company’s lead product, cenicriviroc (CVC), is a first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of non-alcoholic steatohepatitis (NASH) and HIV. Tobira is actively enrolling patients in a Phase 2b clinical trial called CENTAUR to evaluate CVC in patients with NASH and liver fibrosis. Tobira also plans to advance CVC in a fixed-dose combination for HIV type 1 infection through Phase 3 development and commercialization in collaboration with a strategic partner or with non-dilutive financing. Learn more at www.tobiratherapeutics.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this communication regarding the proposed merger and other contemplated transactions (including statements relating to satisfaction of the conditions to and consummation of the proposed merger, the expected ownership of the combined company, the alternatives to the proposed merger, and plans with respect to financing for the combined company) constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control.
Risks and uncertainties for Regado and Tobira and of the combined company include, but are not limited to: inability to complete the proposed merger and other contemplated transactions in connection with the merger; liquidity and trading market for shares prior to and following the consummation of the proposed merger and proposed financing; costs and potential litigation associated with the proposed merger; failure or delay in obtaining required approvals by the SEC or any other governmental or quasi-governmental entity necessary to consummate the proposed merger, including our ability to file an effective proxy statement in connection with the proposed merger and other contemplated transactions in connection with the merger, which may also result in unexpected additional transaction expenses and operating cash expenditures on the parties; an inability or delay in obtaining required regulatory approvals for product candidates, which may result in unexpected cost expenditures; the price of the proposed financing transaction in connection with the proposed merger and contemplated transactions in connection with the merger being materially lower than the trading price of Regado’s common stock at the time of such financing; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; failure to realize any value of certain product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing products; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for the combined company’s products may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; loss of or diminished demand from one or more key customers or distributors; unexpected cost increases and pricing pressures; continuing or deepening economic recession and its negative impact on customers, vendors or suppliers; failure to obtain the necessary stockholder approvals or to satisfy other conditions to the closing of the proposed merger and the other contemplated transactions; a superior proposal being submitted to either party; uncertainties of cash flows and inability to meet working capital needs; cost reductions that may not result in anticipated level of cost savings or cost reductions prior to or after the consummation of the proposed merger; and risks associated with the possible failure to realize certain benefits of the proposed merger, including future financial, tax, accounting treatment, and operating results. Many of these factors that will determine actual results are beyond Regado’s, Tobira’s, or the combined company’s ability to control or predict.
Other risks and uncertainties are more fully described in periodic filings with the Securities and Exchange Commission (the “SEC”), including the factors described in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 filed with the SEC, and in other filings that Regado makes and will make with the SEC in connection with the proposed transactions, including the proxy statement described below under “Important Information and Where to Find It.” Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cause our expectations and beliefs to change. Unless otherwise required by applicable securities laws, we do not intend, nor do we undertake any obligation, to update or revise any forward-looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise. While we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.
Important Information and Where to Find It
Regado and Tobira and certain of their directors and executive officers may become participants in solicitation of proxies from Regado stockholders in connection with the proposed transactions. Additional Information regarding persons who may, under the rules of the SEC, be deemed to be participants in the solicitation of the Regado stockholders in connection with the proposed merger, and who have interests, whether as security holders, directors or employees of Regado or Tobira or otherwise, which may be different from those of Regado stockholders generally, will be provided in the proxy statement and other materials to be filed with the SEC.
Each of Regado’s board of directors, Dennis Podlesak, Jeff Clark, Drew Fromkin, Anton Gopka, Pierre Legault, Michael Mendelsohn, P. Sherrill Neff, Jesse Treu and Michael Metzger; Regado’s executive officers, Michael Metzger (President and Chief Executive Officer) and Don Elsey (Senior Vice President, Finance and Chief Financial and Compliance Officer); Tobira’s board of directors, Eckard Weber, Laurent Fischer, Carol Brosgart, Patrick Heron, Craig Gibbs, Jeffrey Cooper, Dr. Graeme Moyle and Gwen Melincoff; and Tobira’s executive officers, Laurent Fischer (Chief Executive Officer), Christopher Peetz (Chief Financial Officer and Secretary), Eric Lefebvre (Chief Medical Officer), Helen Jenkins (Chief Operating Officer), and Martine Kraus (Vice President, Regulatory Affairs); may be deemed “participants” in the solicitation of proxies from the Regado stockholders in connection with the proposed transactions.
Information regarding the special interests of these directors and executive officers in the merger will be included in the proxy statement referred to above. Additional information regarding Regado’s directors’ and executive officers’ respective interests in Regado by security holdings or otherwise is set forth in Regado’s proxy statement relating to the 2015 annual meeting of stockholders filed with the SEC on May 5, 2014.
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. A definitive proxy statement and a proxy card will be filed with the SEC and will be mailed to Regado’s stockholders seeking any required stockholder approvals in connection with the proposed transactions. BEFORE MAKING ANY VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT REGADO MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS. Stockholders may obtain, free of charge, copies of the definitive proxy statement and any other documents filed by Regado with the SEC in connection with the proposed transactions at the SEC’s website (http://www.sec.gov), at Regado’s website or by writing to the Secretary, Regado, Inc. at 106 Allen Road, Basking Ridge, NJ 07920.
Tobira Contacts:
Chris Peetz
Chief Financial Officer
Tobira Therapeutics
(650) 351-5018
cpeetz@tobiratherapeutics.com
Mark Corbae
Canale Communications
(619) 849-5375
mark@canalecomm.com
Regado Contacts:
Don Elsey
Chief Financial Officer
Regado Biosciences, Inc.
(908) 580-2113
delsey@regadobio.com
David Schull
Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com
(ETRM) FDA Approval of VBLOC® for the Treatment of Obesity
First New Medical Device Approved for Obesity in Over a Decade Novel Neuroscience-Based Technology Enables Safe, Durable Weight Loss Company to Host Conference Call Today at 12:00 PM ET
ST. PAUL, Minn., Jan. 14, 2015 — EnteroMedics Inc. (NASDAQ: ETRM) today announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC® vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years. The Maestro System is the first new medical device to be approved by the FDA for obesity in over ten years. EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
“VBLOC Therapy offers an entirely new approach to the treatment of obesity,” said Scott Shikora, MD, FACS, EnteroMedics’ Chief Consulting Medical Officer. “By blocking signals along the nerves that connect the brain and stomach, VBLOC reduces feelings of hunger and promotes earlier feelings of fullness, which can help people with obesity reduce the number of calories consumed and promote safe, healthy and durable weight loss.”
The Maestro System is a pacemaker-like device that is implanted, usually in an outpatient procedure, to control both hunger and fullness by intermittently blocking the primary nerve which regulates the digestive system, the vagus nerve. VBLOC Therapy does not surgically alter or restrict the digestive system, does not create barriers to prevent absorption of nutrients and is completely reversible, allowing patients to lose weight without lifestyle compromises.
“Obesity is a global epidemic with far-reaching cost and consequences to both public and personal health,” said Caroline M. Apovian, MD, FACP, FACN, Professor of Medicine at Boston University School of Medicine, and Director, Nutrition and Weight Management at Boston Medical Center. “From diet and exercise to bypass surgery, existing treatment options have failed to stop the advance of this disease. The Maestro System adds a safe and effective new weapon to our armamentarium, offering the patient a treatment option that does not physically restrict or alter the anatomy, and is reversible.”
“The Obesity Action Coalition applauds the FDA and EnteroMedics for making available the first device for the treatment of obesity in more than a decade. There is no ‘one-size-fits-all’ approach to treating the disease of obesity. We believe strongly that expanded treatment options are essential to individuals affected by obesity, so that along with their healthcare provider, they can make an informed decision on which option, or options, may work best to improve their health,” said Joe Nadglowski, Obesity Action Coalition President and CEO.
“FDA approval of VBLOC Therapy is a transformational event for not only EnteroMedics and the many supporters who have helped us achieve this milestone but, more importantly, for the people with the disease of obesity that have been waiting for a new option,” said Mark B. Knudson, Ph.D., EnteroMedics’ President and Chief Executive Officer. “The Maestro System fills a significant gap in the currently available treatment options, offering clinically meaningful weight loss without the fear or many of the side effects associated with existing bariatric options. We thank the many patients, and their families, who have participated in the clinical trials of VBLOC Therapy. We are also grateful to the physicians and healthcare providers who have worked with us on these clinical trials, our dedicated employees, as well as to the FDA for their efforts in making this technology available.”
Information about the Maestro System and VBLOC Therapy
Approval of the Maestro Rechargeable System was based on the ReCharge Study, a randomized, double-blind, sham-controlled trial to evaluate the safety and effectiveness of the Maestro Rechargeable System in treating obesity. In an intention to treat (ITT) analysis of the study results, VBLOC-treated patients achieved 24.4% excess weight loss (EWL) at 12 months. At 18 months, VBLOC-treated patients maintained a 23.5% EWL. In a responder analysis of the ITT population at 12 months, over 50% of VBLOC-treated patients achieved 20% or greater EWL.
The SAE (severe adverse event) rate, defined as the proportion of subjects in the VBLOC treated group who experienced an implant/revision procedure, device or therapy-related SAE through 12 months post-implant, was 3.7% (n=6; 95% CI: 1.4% to 7.9%) in the ITT population. The most common (>10%) non-serious adverse events related to device, implant/revision procedure or therapy were pain at the neuroregulator site, and transient sensations of therapy such as heartburn/dyspepsia.
VBLOC Therapy is contraindicated for use in patients with cirrhosis of the liver, portal hypertension, esophageal varices or an uncorrectable, clinically significant hiatal hernia; patients for whom magnetic resonance imaging (MRI) or diathermy use is planned; patients at high risk for surgical complications; and patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis (e.g. pacemakers, implanted defibrillators, neurostimulators).
If you are interested in learning more about VBLOC Therapy, please visit www.enteromedics.com/vbloc or call 1-800-MY-VBLOC.
For additional prescribing information, please visit www.enteromedics.com.
Multimedia Release
A multimedia version of this release, with links to graphics and additional background information can be found at: http://www.multivu.com/players/English/7269351-enteromedics-fda-approval-vbloc-maestro-system-weight-loss-device.
Obesity Facts and Figures
According to the CDC, more than one-third of U.S. adults live with obesity1. The estimated annual cost of obesity in the U.S. was $147 billion in 2008, accounting for more than twice previous estimates, approximately 21 percent, of U.S. healthcare costs.2,3 Higher BMI is a major risk factor for over 70 comorbidities associated with obesity, such as cardiovascular disease which was the leading cause of death in 2012, diabetes, hypertension, musculoskeletal disorders and some cancers.4
Conference Call for Investors
EnteroMedics will host a webcast and conference call for investors to discuss the recent FDA action today at 12:00 PM Eastern Time (9:00 AM Pacific Time). To participate, please dial (877) 280-7473 (US) or (707) 287-9370 (International). Use conference ID 67146231. To access a live audio webcast of the conference call, please visit “Events” under “Investors” section on the company’s website at: www.enteromedics.com.
A replay of the call will be made available from 3:00 PM ET on January 15, 2015 until April 14, 2015 at 11:59 PM ET. To hear a replay of the call, dial (855) 859-2056 (US) or (404) 537-3406 (International). A replay of the call will also be available under “Events” in the “Investors” section on the company’s website at: www.enteromedics.com.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. VBLOC® vagal blocking therapy, delivered by a pacemaker-like device called the Maestro® System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses, which helps control both hunger and fullness. VBLOC allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort. EnteroMedics’ Maestro Rechargeable System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial sales experience with our Maestro® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our preliminary findings from our EMPOWER™ and ReCharge pivotal trials; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and VBLOC® vagal blocking therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the annual report on Form 10-K filed March 27, 2014. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Important Safety Information
Talk with your doctor about the full risks and benefits of VBLOC® Vagal Blocking Therapy and the Maestro® Rechargeable System.
What is the Maestro System Used For:
The Maestro System is for use in helping with weight loss in people aged 18 years through age 65 who are obese, with a Body Mass Index (BMI) of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels. Individuals should have first tried to lose weight by diet and exercise in a supervised program within the last 5 years before receiving the Maestro System.
Contraindications:
You should not have an implanted Maestro Rechargeable System if you have cirrhosis (a disease of the liver), portal hypertension (high blood pressure in the veins of the liver), esophageal varices (enlarged veins at the lower end of the tube between the mouth and the stomach) or an uncorrectable, clinically significant hiatal hernia (a condition where part of the stomach pushes up or through the diaphragm where the tube between the mouth and the stomach passes through to connect to the stomach); patients for whom magnetic resonance imaging (a type of medical imaging that uses strong magnets and pulses of radio waves) is planned; patients at high risk for surgical complications; patients who have a permanently implanted, electrical-powered medical device; or patients for whom diathermy (a type of medical procedure that heats and destroys tissue) is planned.
Warnings/Precautions/Adverse Events:
Seek guidance from your doctor before you undergo a medical or surgical procedure, as interaction of the Maestro System with certain medical therapies, procedures or other implanted or body worn medical devices may harm you, cause damage to the implanted device or may turn therapy off. These may include, but are not limited to, lithotripsy (use of high energy shock waves to break up stones), radiation, mono polar electrosurgical instruments (a type of surgical instrument), positron emission tomography scans (a type of medical imaging), radiofrequency ablation (a method of destroying tissue used during surgery), heart pacemakers or defibrillators, neurostimulators, and insulin pumps. Turning, twisting, or manipulating the implanted components may damage the nerves or implanted device. System components must be kept charged to prevent damage, which may require additional surgery to replace the implanted device. The neuroregulator should be fully charged prior to turning it off. The Maestro System is MR Unsafe, including for patients in which the Maestro System was explanted and not all components were removed. Portable outlets or extension cords should not be connected to the AC recharger. Do not immerse external system components in fluid. Keep strong magnets at least 6 inches away from the implanted device. The Maestro Rechargeable System may activate metal detectors or other security systems. Strong magnetic fields systems that emit radio frequency signals may interfere with the function of the Maestro System. The neuroregulator and mobile charger should be turned off near metal detectors, other security systems, strong magnetic fields and radio frequency emitting systems. The mobile charger should be turned off while aboard aircraft. Infection at the implant site may occur and could require use of antibiotic medications, surgery, or explant. Do not modify any components of the system. Safety and effectiveness of the Maestro Rechargeable System has not been established for use within a hyperbaric chamber (chamber designed to supply oxygen at a higher than normal air pressure), with external defibrillation, during pregnancy, or for use in patients under 18 years of age. The capacity of the rechargeable neuroregulator battery will diminish over time, requiring longer or more frequent charging. Do not operate the system in flammable environments, or if components appear damaged. Do not cover the mobile charger when in use to prevent overheating and damage. You may not be able to operate the Maestro System if you have impaired vision. Make sure all of your health care providers are aware that you have an implanted Maestro System.
The most common related adverse events that were experienced during clinical study of the Maestro Rechargeable System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.
1 Prevalence of Childhood and Adult Obesity in the United States, 2011-2012 Cynthia L. Ogden, PhD1; Margaret D. Carroll, MSPH1; Brian K. Kit, MD, MPH1,2; Katherine M. Flegal, PhD1 JAMA. 2014;311(8):806-814. doi:10.1001/jama.2014.732.
2 Cawley, John, and Chad Meyerhoefer. “The Medical Care Costs of Obesity: An Instrumental Variables Approach.” Journal of Health Economics 31.1 (2012): 219-30.
3 Eric A. Finkelstein, Justin G. Trogdon, Joel W. Cohen and William Dietz Annual Medical Spending Attributable To Obesity: Payer-And Service-Specific Estimates Health Affairs, 28, no.5 (2009):w822-w831 (published online July 27, 2009; 10.1377/hlthaff.28.5.w822)
4 Cawley, John, and Chad Meyerhoefer. “The Medical Care Costs of Obesity: An Instrumental Variables Approach.” Journal of Health Economics 31.1 (2012): 219-30.
(SMSI) Preliminary Q4 2014 Revenue and Profits, Fiscal 2015 Guidance
ALISO VIEJO, CA–(Jan 14, 2015) – Smith Micro Software, Inc. (NASDAQ: SMSI), a leading provider of wireless and mobility solutions, today announced preliminary revenue and non-GAAP operating profits for its fiscal fourth quarter ended December 31, 2014. The Company also gives guidance for fiscal 2015 ahead of its scheduled presentation and investor meetings today at the Needham & Company Annual Growth Conference in New York City.
Fiscal 2014 Fourth Quarter Selected Preliminary Financial Results:
- Revenue for the fiscal 2014 fourth quarter is expected to be between $10.4 million and $10.6 million.
- Non-GAAP operating profit for the fiscal 2014 fourth quarter is expected to be in the range of $600,000 to $700,000.
- Cash and short-term investments at December 31, 2014 will be approximately $13.0 million.
Fiscal 2015 Guidance:
- Revenue for the first quarter is expected to be equal to, or slightly higher than, the fourth quarter of fiscal 2014.
- Revenue for fiscal 2015 is expected to be between $45 million and $49 million.
- The Company expects to be non-GAAP profitable for the fiscal year 2015.
“The turnaround that started in the third quarter of this fiscal year continues,” said William W. Smith Jr., Smith Micro’s President and Chief Executive Officer. “We are very excited about our return to profitability, solid sequential revenue growth, and new deals that will continue to increase revenues next year and hopefully for years to come. As we look to fiscal 2015, our expectation is that we will remain profitable for the entire year while achieving steady quarterly revenue growth throughout the year.”
These results are based on preliminary information as of today, are unaudited, and are subject to change. The Company plans to announce final fourth quarter and fiscal year 2014 financial results on February 24, 2015.
Conference Details:
Smith Micro will be presenting at the Needham & Company 17th Annual Growth Conference on Wednesday, January 14, 2015 at 8:40 a.m. Eastern Time. The conference is being held at the New York Palace Hotel in New York City. The Company will offer a live audio webcast of its presentation at 8:40 a.m. Eastern Time on January 14, 2015 at http://wsw.com/webcast/needham69/smsi as well as an archived replay, which will be available on the Smith Micro website in the Investor Relations section.
About Smith Micro Software:
Smith Micro Software provides solutions that simplify, secure and enhance the mobile experience. Our portfolio includes a wide range of applications that manage broadband connectivity, data traffic, devices, voice and video communications over wireless networks. With 30 years of experience developing world-class client and server software, Smith Micro helps the leading mobile network operators, device manufacturers and enterprises increase efficiency and capitalize on the growth of mobile-connected consumers and workforces. For more information, visit smithmicro.com. (NASDAQ: SMSI)
Safe Harbor Statement:
This release contains forward-looking statements that involve risks and uncertainties, including without limitation, forward-looking statements relating to the company’s financial prospects and other projections of its performance, the existence of new market opportunities and interest in the company’s products and solutions, and the company’s ability to increase its revenue and regain profitability by capitalizing on these new market opportunities and interest and introducing new products and solutions. Among the important factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements are changes in demand for the company’s products from its customers and their end-users, new and changing technologies, customer acceptance of those technologies, customer concentration given that the majority of our sales depend on a few large client relationships, including Sprint, and the company’s ability to compete effectively with other software companies. These and other factors discussed in the company’s filings with the Securities and Exchange Commission, including its filings on Forms 10-K and 10-Q, could cause actual results to differ materially from those expressed or implied in any forward-looking statements. The forward-looking statements contained in this release are made on the basis of the views and assumptions of management regarding future events and business performance as of the date of this release, and the company does not undertake any obligation to update these statements to reflect events or circumstances occurring after the date of this release.
Smith Micro and the Smith Micro logo are registered trademarks or trademarks of Smith Micro Software, Inc. Third-party trademarks mentioned are the property of their respective owners.
AT THE COMPANY:
Suzanne Runald
Public Relations
949-362-5800
Email Contact
IR INQUIRIES:
Todd Kehrli or Jim Byers
MKR Group, Inc.
323-468-2300
Email Contact
(MRCY) $4.3M Order for High Performance Signal Processing Subsystems
CHELMSFORD, Mass. — January 13, 2015 — Mercury Systems, Inc. (Nasdaq:MRCY) (www.mrcy.com), a leading high-tech commercial provider of more affordable secure and sensor processing subsystems powering today’s critical defense and intelligence applications, announced it received a $4.3 million follow-on order from a leading defense prime contractor for high performance signal processing subsystems for a ship-borne radar application. The order was booked in the Company’s fiscal 2015 second quarter and is expected to be shipped by its fiscal 2016 third quarter.
“We are extremely pleased to continue our relationship with this longstanding customer,” said Didier Thibaud, President of Mercury’s Commercial Electronics business unit. “Mercury’s commitment to providing the most advanced and reliable signal processing systems and architecture has ensured our continued participation in this mission-critical defense program.”
For more information on Mercury Systems, visit www.mrcy.com or contact Mercury at (866) 627-6951 or info@mrcy.com.
Mercury Systems – Innovation That Matters™
Mercury Systems (Nasdaq:MRCY) is the better alternative for affordable, secure and sensor processing subsystems designed and made in the USA. Optimized for program and mission success, Mercury’s solutions power a wide variety of critical defense and intelligence applications on more than 300 programs such as Aegis, Patriot, SEWIP, F-35 and Gorgon Stare. Headquartered in Chelmsford, Massachusetts, Mercury Systems is a high-tech commercial company purpose-built to meet rapidly evolving next-generation defense electronics challenges. To learn more, visit www.mrcy.com.
Forward-Looking Safe Harbor Statement
This press release contains certain forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995, including those relating to the products and services described herein. You can identify these statements by the use of the words “may,” “will,” “could,” “should,” “would,” “plans,” “expects,” “anticipates,” “continue,” “estimate,” “project,” “intend,” “likely,” “forecast,” “probable,” and similar expressions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. Such risks and uncertainties include, but are not limited to, continued funding of defense programs, the timing of such funding, general economic and business conditions, including unforeseen weakness in the Company’s markets, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technological advances and delivering technological innovations, changes in the U.S. Government’s interpretation of federal procurement rules and regulations, market acceptance of the Company’s products, shortages in components, production delays due to performance quality issues with outsourced components, inability to fully realize the expected benefits from acquisitions and restructurings or delays in realizing such benefits, challenges in integrating acquired businesses and achieving anticipated synergies, changes to export regulations, increases in tax rates, changes to generally accepted accounting principles, difficulties in retaining key employees and customers, unanticipated costs under fixed-price service and system integration engagements, and various other factors beyond our control. These risks and uncertainties also include such additional risk factors as are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended June 30, 2013. The Company cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. The Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made.
Mercury Systems and Innovation That Matters are trademarks of Mercury Systems, Inc. Other product and company names mentioned may be trademarks and/or registered trademarks of their respective holders.
CONTACT: Robert McGrail, Director of Corporate Communications Mercury Systems +1 978-967-1366 / rmcgrail@mrcy.com
(JMBA) Agrees to Appoint Two New Independent Directors
Jamba, Inc. (NASDAQ:JMBA), a leading health and wellness brand and the leading retailer of freshly squeezed juice, today announced that it has entered into an agreement to appoint James C. Pappas, Managing Member of JCP Investment Management, LLC, and Glenn W. Welling, Managing Member and Chief Investment Officer of Engaged Capital, LLC, to its Board of Directors, effective immediately, and that each will be included in Jamba’s slate of director nominees for election at the 2015 Annual Meeting of Stockholders (the “2015 Annual Meeting”). Jamba also agreed that one current member of the Board would not be re-nominated to stand for election at the 2015 Annual Meeting. With these changes, after the 2015 Annual Meeting the Jamba Board will comprise nine directors, eight of whom are independent.
James D. White, chairman, president and CEO of Jamba, said, “We are pleased to welcome Glenn and James to the Board of Directors, and are confident that their diversified expertise will add valuable perspective to Jamba’s Board as we continue to execute on our growth strategy. Jamba is focused on driving shareholder value as we expand our juicing platform and transition to an asset-light, franchise-focused model. We believe that including representatives from two of Jamba’s large investors is in the best interest of the Company and all shareholders.”
James C. Pappas of JCP Investment Management said, “We are pleased to join Jamba’s Board. We look forward to working with management and the Board to help enhance value for all stockholders.”
Glenn W. Welling of Engaged Capital said, “We appreciate Jamba’s constructive approach and the recent steps that have been taken to enhance shareholder value. Jamba’s commitment to transition to a franchise focused company has the potential to create meaningful value for shareholders, and I look forward to being a part of the team that makes that happen.”
Under the terms of the agreement with Engaged Capital, LLC and certain of its affiliates (“Engaged Capital”), which beneficially own approximately 8.2% of the Company’s outstanding shares, and JCP Investment Management, LLC and certain of its affiliates (“JCP”), which beneficially own approximately 2.3% of the Company’s outstanding shares, JCP and Engaged Capital have agreed to vote their shares in favor of the election of the Company’s slate of directors at the Company’s 2015 Annual Meeting. In addition, JCP will, among other things, withdraw its nomination of candidates to stand for election at the Company’s 2015 Annual Meeting and has agreed to customary standstill provisions through the date that is 45 days prior to the expiration of the Company’s advance notice period for the nomination of directors at the Company’s 2016 Annual Meeting of Stockholders. The full agreement will be filed in a Form 8-K with the Securities and Exchange Commission later today.
Mr. Pappas will serve as a member of the Board’s Nominating and Corporate Governance Committee and as a member of the Audit Committee, and Mr. Welling will serve as a member of the Compensation and Executive Development Committee. The date of the 2015 Annual Meeting has not been set.
About James C. Pappas
James C. Pappas is the Managing Member of JCP Management and the sole member of JCP Holdings. Mr. Pappas has served on the Board of Directors of The Pantry, Inc. (NASDAQ:PTRY), a leading independently operated convenience store chain in the southeastern United States and one of the largest independently operated convenience store chains in the country, since March 2014. Previously, Mr. Pappas served as Chairman of the Board of Directors of Morgan’s Foods, a then publicly traded company, from January 2013 until May 2014, when the company was acquired by Apex Restaurant Management, Inc. Mr. Pappas joined the Board of Morgan’s Foods in February 2012, where he also served as Chairman of the Compensation and Leadership Committee. From 2005 until 2007, Mr. Pappas worked for The Goldman Sachs Group, Inc. (NYSE:GS) in their Investment Banking / Leveraged Finance Division. As part of the Goldman Sachs Leveraged Finance Group, Mr. Pappas advised private equity groups and corporations on appropriate leveraged buyout, recapitalization and refinancing alternatives. Prior to Goldman Sachs, Mr. Pappas worked at Banc of America Securities, the investment banking arm of Bank of America (NYSE:BAC), where he focused on Consumer and Retail Investment Banking, providing advice on a wide range of transactions including mergers and acquisitions, financings, restructurings and buyside engagements. Mr. Pappas received a BBA, and a Masters in Finance from Texas A&M University.
About Glenn W. Welling
Glenn W. Welling is the Founder and Chief Investment Officer of Engaged Capital, LLC, a California based investment firm and registered advisor with the SEC focused on investing in small and mid-cap North American equities. Prior to founding Engaged Capital in February 2012, Mr. Welling was Principal and Managing Director at Relational Investors LLC (“Relational”), a $6 billion activist equity fund and registered investment adviser with the SEC, from June 2008 to October 2011 and served as its consultant from October 2011 until April 2012. Mr. Welling managed Relational’s consumer, healthcare and utility investments and was responsible for investment selection, strategic development and catalyzing change at Relational’s portfolio companies. Prior to Relational and from February 2002 to May 2008, Mr. Welling was a Managing Director at Credit Suisse Group AG (“Credit Suisse”) (NYSE:CS), a leading global financial services company, where he was the Global Head of the Investment Banking Department’s Advisory Businesses, which included The Buy-Side Insights (HOLT) Group, Financial Strategy Group and Ratings Advisory Group. Previously, Mr. Welling served as Partner and Managing Director of HOLT Value Associates L.P. (“HOLT”), a then leading provider of independent research and valuation services to asset managers, from October 1999 until January 2002 when HOLT was acquired by Credit Suisse. Prior to HOLT, he was the Managing Director of Valuad U.S., a financial software and training company, and senior manager at A.T. Kearney, one of the world’s largest global management consulting firms. Mr. Welling also teaches executive education courses at The Wharton School of Business and is a frequent speaker at finance and investing conferences. He graduated from The Wharton School of the University of Pennsylvania where he currently serves as the Chairman of the school’s tennis program and as a member of the Wharton School’s Executive Education Board.
About Jamba Juice Company
Founded in 1990, Jamba, Inc. is a leading restaurant retailer of better-for-you, specialty beverage and food offerings, which include great tasting, whole fruit smoothies, fresh squeezed juices and juice blends, hot teas, and a variety of food items including hot oatmeal, breakfast wraps, sandwiches, Artisan Flatbreads™, baked goods, and snacks. As of September 30, 2014, there were 807 Jamba Juice store locations globally. Jamba is a proud sponsor of “Team Up for a Healthy America” in the fight against childhood obesity and encourages fans to join the Team Up community of celebrities, athletes, and other leaders committed to getting kids active and involved at www.myhealthpledge.com. Fans of Jamba Juice can find out more about Jamba Juice’s locations as well as specific offerings and promotions by visiting the Jamba Juice website at www.JambaJuice.com or by contacting Jamba’s Guest Services team at 1-866-4R-FRUIT (473-7848).
Forward-Looking Statements
This press release (including information incorporated or deemed incorporated by reference herein) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are those involving future events and future results that are based on current expectations, estimates, forecasts, and projections as well as the current beliefs and assumptions of the Company’s management. Words such as “outlook”, “believes”, “expects”, “appears”, “may”, “will”, “should”, “anticipates”, or the negative thereof or comparable terminology, are intended to identify such forward looking statements. Any statement that is not a historical fact and any other estimates, projections, future trends and the outcome of events that have not yet occurred, is a forward-looking statement. Forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore actual results may differ materially and adversely from those expressed in any forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to factors discussed under the section entitled “Risk Factors” in the Company’s reports filed with the SEC. Many of such factors relate to events and circumstances that are beyond the Company’s control. You should not place undue reliance on forward-looking statements. The Company does not assume any obligation to update the information contained in this press release.
Investor Relations
Dara Dierks, 646-277-1212
investors@jambajuice.com
or
Media Relations
Mike Fuccillo, 510-596-0100, X-7
Dir. Corporate Communications
mfuccillo@jambajuice.com
(ICEL) & Cord Blood Registry Collaboration to Reprogram Newborn Stem Cells into Pluripotent
SAN BRUNO, Calif. and MADISON, Wis., Jan. 13, 2015 — Cord Blood Registry® (CBR®) and Cellular Dynamics International (NASDAQ: ICEL) (CDI) announced today that they have entered into a research collaboration to reprogram newborn stem cells from both umbilical cord blood and umbilical cord tissue collected, processed and cryopreserved under CBR’s protocols into induced pluripotent stem cells (iPSCs) using CDI’s proprietary methods.
Through this research collaboration, CBR will provide to CDI multiple de-identified, research-donated and cryopreserved umbilical cord blood units as well as multiple de-identified units of mesenchymal stem cells (MSCs) isolated from previously cryopreserved cord tissue. CDI will reprogram the cells into iPSCs and confirm their pluripotent nature.
iPSCs, cells that have the ability to replicate indefinitely and to differentiate into any cell type in the human body, are one of the most promising frontiers in human medicine. Once an iPSC line is created, it becomes a renewable source of starting material for differentiation into any tissue of the body. iPSCs are currently used by researchers in disease modeling, drug screening and in the early stages of cell-based therapy clinical trials. A patient-specific iPSC line would have significant potential in future cell therapies as any tissue differentiated from those iPSCs would be a perfect genetic match to the individual from whose cells the original line was created.
Hematopoietic stem cells (HSCs), like those found in umbilical cord blood, and MSCs, like those found in cord tissue, have previously been shown by researchers to be reprogrammable into iPSCs (Mack, 2011 and Cai, 2010). However, this research collaboration will be unique in that a leader in iPSC technology and the world’s largest cord blood bank have partnered to establish a workflow to allow HSCs and MSCs collected and cryopreserved at birth by CBR to be later reprogrammed into iPSCs for individuals.
“CBR is excited to enter into this research collaboration with CDI, a leader in iPSC technology,” said Geoffrey Crouse, President and CEO of CBR. “Establishing a repeatable process, by which CBR’s clients can have their newborn stem cells reprogrammed to become induced pluripotent stem cells, has the potential to increase the future utility of the cells we store in our bank. The stem cells our clients have stored are particularly unique as a starting material as they are collected at birth and typically undamaged by age, disease and environmental factors that may be encountered through life.”
“We look forward to applying CDI’s proprietary episomal reprogramming technique to create iPSCs from cells stored in CBR’s bank,” said Bob Palay, Chairman and CEO of CDI. “Our goal is for the families who have entrusted CBR to store newborn stem cells from more than 500,000 children to know that they can have CDI establish a line of individualized iPSCs that matches their own genetic material. Given the rate of clinical advancements in iPSCs and their capacity to differentiate into different tissues, the ability to create a pluripotent stem cell from newborn stem cells has the potential to become a very valuable resource to treat disease.”
About Cord Blood Registry
Cord Blood Registry® (CBR®) is the world’s largest newborn stem cell company. Founded in 1994, CBR is entrusted by parents with storing more than 500,000 cord blood and cord tissue units. CBR is dedicated to advancing the clinical application of newborn stem cells by partnering with leading research institutions to establish FDA-regulated clinical trials, for conditions that have no cure today. For more information, visit cordblood.com.
About Cellular Dynamics, Inc.
Cellular Dynamics International, Inc. is a leading developer and manufacturer of fully functioning human cells in industrial quantities to precise specifications. CDI’s proprietary iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell Products). CDI’s iCell O/S products provide standardized, easy-to-use, cost-effective access to the human cell, the smallest fully functioning operating unit of human biology. Customers use our iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in the research and development of cellular therapeutics. CDI was founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research at the University of Wisconsin-Madison. CDI’s facilities are located in Madison, Wisconsin, with a second facility in Novato, California. See www.cellulardynamics.com.
Forward-looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Cellular Dynamics International, Inc., including statements regarding the reprogramming of iPSCs from newborn stem cells and their potential value for treatment of disease, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our product development efforts, actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Cellular Dynamics undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Cellular Dynamics’ Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on March 11, 2014, which risks are incorporated herein by reference, and as may be described from time to time in Cellular Dynamics’ subsequent SEC filings.
References:
Mack AA, Kroboth S, Rajesh D, Wang WB. Generation of Induced Pluripotent Stem Cells from CD34+ Cells across Blood Drawn from Multiple Donors with Non-Integrating Episomal Vectors. PLoS ONE 2011;6(11): e27956.
Cai J, Li W, Su H, et al. Generation of Human Induced Pluripotent Stem Cells from Umbilical Cord Matrix and Amniotic Membrane Mesenchymal Cells. J. Biol Chem. 2010;285(15)11227-11234.
(CLTX) Completes Enrollment of Phase II Trial of MRX-6 Cream 2% in Pediatric Atopic Dermatitis
Topline Data From Double-Blind Portion of Trial Expected by End of February, 2015
NEW YORK and LONDON, Jan. 13, 2015 — Celsus Therapeutics (Nasdaq:CLTX), an emerging growth, development-stage biopharmaceutical company, announced today that the Company has completed enrollment of C012013, a Phase II, double-blind, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of MRX-6 cream 2% in a pediatric population with mild to moderate atopic dermatitis. The trial enrolled 73 children with mild to moderate atopic dermatitis into a four-week double-blind period, followed by a four-week open label extension for those patients who wish to continue in the trial. Topline data from the double blind portion of the trial are expected by end-February, 2015.
“The completion of enrollment of the C012013 Phase II trial represents an important milestone for both the company and the MRX-6 program,” said Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. “This trial will provide important insight into the activity of MRX-6 in pediatric atopic dermatitis, and we are thankful for the deep interest and support demonstrated by the parents and children with atopic dermatitis who enrolled in our trial and by our investigators. We believe MRX-6 will provide a safe and effective alternative to topical steroids and calcineurin inhibitors for children and adults suffering from atopic dermatitis.”
About Celsus Therapeutics Plc
Celsus Therapeutics is an emerging clinical stage company focused on the development of a new class of non-steroidal, synthetic anti-inflammatory drugs termed Multi-Functional Anti-Inflammatory Drugs or MFAIDs. Celsus’s MFAIDs represent a new therapeutic platform for the treatment of a broad array of inflammatory diseases, such as inflammatory and autoimmune diseases. Presently, the Company’s lead drug candidate in its clinical pipeline is MRX-6, an MFAID topical cream treatment under development for treating skin inflammatory disorders, specifically atopic dermatitis, also known as eczema. Other potential treatments in preclinical development include OPX-1 for ocular inflammation, CFX-1 for cystic fibrosis, and OAX-1 for osteoarthritis.
FORWARD-LOOKING STATEMENTS – This press release contains “forward-looking statements” that involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” “hope,” “look forward” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 20-F discusses some of the important risk factors that may affect our business, results of operations and financial condition. Unless we are required to do so under applicable laws, we do not intend to update or revise any forward-looking statements.
CONTACT: Investor Relations Contact The Trout Group Tricia Truehart ttruehart@troutgroup.com 646-378-2953
(NLST) Wins Major Legal Victory in Trade Secret, Breach of Contract Against Diablo Tech
Federal Court Orders Halt to Sales of New High-Speed Computer Chips Used by SanDisk, IBM and Other OEMs
Netlist Wins Major Legal Victory in Trade Secret, Breach of Contract Lawsuit Against Diablo Technologies, Inc. in Case Involving ULLtraDIMM SSD In Rare Step, Federal Court Orders a Preliminary Injunction Against Diablo Technologies and its Controller Chips Used in Products by SanDisk, IBM, Lenovo, Huawei, and SupermicroOAKLAND, Calif., Jan. 13, 2015 — A federal district court judge took the rare step of ordering a preliminary injunction against a Canadian company from manufacturing, using, distributing or selling high-speed memory controller chips used by SanDisk and other major computer manufacturers.
Netlist, Inc. (NASDAQ: NLST) announced that Judge Yvonne Gonzalez Rogers of the United States District Court for the Northern District of California granted Netlist’s Motion for Preliminary Injunction against Diablo Technologies, Inc., for controller chips used by SanDisk in its high-speed ULLtraDIMM SSD product line. Under the Court’s order, Diablo and SanDisk are prohibited from manufacturing and selling the controller chipset used by SanDisk in the ULLtraDIMM and as a result, from further sale or distribution of the ULLtraDIMM itself.
Judge Gonzalez Rogers found that “the evidence indicates that Netlist is likely to prevail by showing that the Netlist Technology … was used by Diablo to develop” its controller chips. “By misusing the technology that Diablo had been given in confidence under the Supply Agreement [with Netlist], Diablo gained an advantage it would not have otherwise had.” In the Court’s Order, Judge Gonzalez Rogers rejected Diablo’s arguments that it somehow had rights to use Netlist’s chipset and technology under the agreements.
The judge also rejected SanDisk’s motion for reconsideration, asking that it be allowed to sell existing inventory of the enjoined products. The Court found that the injunction properly barred SanDisk from selling these products after a careful review of the long contractual partnership between Diablo and SanDisk with respect to the ULLtraDIMM module, finding that SanDisk and Smart Storage “are ‘persons who are in active concert with’ Diablo.”
The Court advanced the trial date by four months, to March 9, 2015, for Netlist’s claims upon which the motion was decided, including claims against Diablo for trade secret misappropriation, breach of contract, and other causes of action related to the components supplied by Diablo for the ULLtraDIMM. The Court’s order specifically identifies the ULLtraDIMM as well as the eXFlash modules from IBM, although the injunction affects all modules containing Diablo components. Other OEMs, including Huawei, Lenovo and Supermicro, have announced plans to offer ULLtraDIMMs in certain of their server platforms.
Netlist created and patented ground-breaking memory interface technology which significantly increases the speed of servers. It contracted with Diablo to implement a proprietary memory-controller chipset based on this technology, only to find that Diablo stole its trade secrets and incorporated them into Diablo’s own products.
“We are very pleased with the court’s decision”, said C.K. Hong, Netlist’s Chief Executive Officer. “We believe this extraordinary legal ruling is a validation of what we’ve said from the beginning about Diablo’s flagrant actions. The ruling serves as a major step towards establishing the rightful ownership of the intellectual property contained in the ULLtraDIMM, and clears the path for Netlist products based on our proprietary memory interface technology. We look forward to the opportunity to present all of the evidence to a jury, particularly given the court’s assessment of our likelihood of prevailing.”
A preliminary injunction requires proof of likelihood of success on the merits of the claims, and that irreparable injury will result if the motion is not granted. The Court found that the trade secret and breach of contract claims substantially overlap, and that Netlist’s “conclusive showing on the contract claim means that the court need not reach the question of likelihood of success on the trade secret claims” in order to grant the preliminary injunction. The Court observed that “the showing of a head-start advantage to Diablo, based upon an improper use of Netlist’s technology, is sufficient to establish” irreparable harm. The Court also considered how Diablo’s unlawful conduct has harmed Netlist’s efforts to develop and sell its own NVvault and HyperVaultproducts. A permanent injunction may be issued after trial for the entire wrongful head-start period.
The decision follows another important legal victory by Netlist in the dispute. Last month, the United States Patent and Trademark Office (USPTO) denied petitions filed by SanDisk requesting Inter Partes Review (IPR) of Netlist patents asserted against the ULLtraDIMM in a separate patent infringement suit brought by Netlist against SanDisk and Diablo, before the same court. SanDisk and Diablo are now barred from filing additional IPRs on the four Netlist patents with claims that the PTAB refused to review.
About Netlist:
Netlist, Inc. designs and manufactures high-performance, logic-based memory subsystems for server and storage applications for cloud computing. Netlist’s flagship products include NVvault™ and EXPRESSvault™ family of hybrid memory products that significantly accelerate system performance and provide mission critical fault tolerance, HyperCloud®, a patented memory technology that breaks traditional performance barriers, and a broad portfolio of industrial Flash and specialty memory subsystems including VLP (very low profile) DIMMs and Planar-X RDIMMs. Netlist has steadily invested in and grown its worldwide IP portfolio, which now includes 81 issued and pending patents in the areas of high performance memory and hybrid memory technologies.
Netlist develops technology solutions for customer applications in which high-speed, high-capacity, small form factor and efficient heat dissipation are key requirements for system memory. These customers include OEMs and hyperscale datacenter operators that design and build servers, storage systems and high-performance computing clusters, engineering workstations and telecommunications equipment. Founded in 2000, Netlist is headquartered in Irvine, CA with manufacturing facilities in Suzhou, People’s Republic of China. Learn more at www.netlist.com.
Safe Harbor Statement:
This news release contains forward-looking statements regarding future events and the future performance of Netlist. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expected or projected. These risks and uncertainties include, but are not limited to, risks associated with the launch and commercial success of our products, programs and technologies; the success of product partnerships; continuing development, qualification and volume production of EXPRESSvault™, NVvault™, HyperCloud® and VLP Planar-X RDIMM; the timing and magnitude of the anticipated decrease in sales to our key customer; our ability to leverage our NVvault™ technology in a more diverse customer base; the rapidly-changing nature of technology; risks associated with intellectual property, including patent infringement litigation against us as well as the costs and unpredictability of litigation over infringement of our intellectual property and the possibility of our patents being reexamined by the United States Patent and Trademark office; volatility in the pricing of DRAM ICs and NAND; changes in and uncertainty of customer acceptance of, and demand for, our existing products and products under development, including uncertainty of and/or delays in product orders and product qualifications; delays in the Company’s and its customers’ product releases and development; introductions of new products by competitors; changes in end-user demand for technology solutions; the Company’s ability to attract and retain skilled personnel; the Company’s reliance on suppliers of critical components and vendors in the supply chain; fluctuations in the market price of critical components; evolving industry standards; and the political and regulatory environment in the People’s Republic of China. Other risks and uncertainties are described in the Company’s annual report on Form 10-K filed on March 18, 2014, and subsequent filings with the U.S. Securities and Exchange Commission made by the Company from time to time. Except as required by law, Netlist undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(LLEX) Secures Credit Facility With Heartland Bank for Up to $50 Million
Capital Provides Foundation for Company’s Drilling and Acquisition Programs
DENVER, Jan. 13, 2015 — Lilis Energy (Nasdaq:LLEX), a domestic oil and gas exploration and production company focused in the Denver-Julesburg Basin (DJ Basin), today announced that it has secured a credit facility with Heartland Bank in Little Rock, Arkansas as administrative agent for up to $50 million.
“We believe that the current oil and gas market provides tremendous opportunities to pursue acquisitions of producing and reserve-rich assets at favorable valuations in the DJ Basin and in other attractive opportunities throughout North America. Our number one priority is to utilize this capital to increase production and drive reserve growth,” stated Avi Mirman, CEO of Lilis Energy. “I would like to thank the Heartland Bank team and especially Greg White, Senior Credit Analyst, and Phil Thomas, Chief Lending Officer, for their efforts in helping us put together this financing package that we believe will allow us to continue to execute on our business strategy.”
The Credit Agreement provides for a three-year senior secured term loan in an initial aggregate principal amount of $3,000,000, which principal amount may be increased to a maximum principal amount of $50,000,000, subject to certain conditions, including lender approval of additional advances. The credit facility will bear interest at the Prime Rate plus an applicable margin ranging from 6.25% to 8.5%. Funds borrowed under the agreement are designated to be used to purchase oil and gas assets, fund certain lender-approved development projects, fund a debt service reserve account, pay all costs and expenses arising in connection with the negotiation and execution of the credit agreement, and fund the company’s general working capital needs. The credit facility has a maturity date of January 8, 2018, with all outstanding principal due at maturity, subject to a 3% prepayment premium on prepayments made prior to January 8, 2016. The amount the Company can borrow under the credit facility is based upon a debt-to-EBITDAX calculation and a debt coverage ratio based on the value of oil and gas reserves. All of Lilis Energy’s assets, including all of its properties, have been designated as collateral under the arrangement.
The Company paid a nonrefundable commitment fee to Heartland Bank in the amount of $75,000 in connection with the loan, and agreed to issue to Heartland Bank 75,000 five-year warrants at $2.50 per share, for every $1 million funded. An initial warrant to purchase up to 225,000 shares of the Company’s common stock was issued in connection with closing.
Roth Capital Partners sourced the credit facility and acted as exclusive financial advisor to Lilis Energy in the transaction. Please see the Company’s Current Report on Form 8-K to be filed with the SEC on January 13, 2015 for additional details regarding the credit facility.
About Lilis Energy, Inc.
Lilis Energy, Inc. is a Denver-based independent oil and gas exploration and production company that operates in the Denver-Julesburg (DJ) Basin, where it holds approximately 93,000 gross, 84,000 net acres. Lilis Energy’s near-term E&P focus is to grow reserves and production in its Wattenberg Field acreage targeting the Niobrara benches and Codell Sandstone. For more information, please contact MDC Group (414) 351-9758 or visit www.lilisenergy.com.
Forward-Looking Statements
This press release may include or incorporate by reference “forward-looking statements” as defined by the SEC, including statements, without limitation, regarding Lilis Energy’s expectations, beliefs, intentions or strategies regarding the future. These statements are qualified by important factors that could cause Lilis Energy’s actual results to differ materially from those reflected by the forward-looking statements. Such factors include but are not limited to Lilis Energy’s ability to finance its continued exploration, drilling operations and working capital needs, and the general risks associated with oil and gas exploration and development, including those risks and factors described from time to time in Lilis Energy’s reports and registration statements filed with the SEC.
MDC GROUP
Investors:
David Castaneda or Arsen Mugurdumov
414.351.9758
Media:
Susan Roush
747.222.7012
(AGEN) “2015: Poised To Be Another Transformative Year for Agenus”
NEW YORK, NY – January 12, 2015 / Agenus, Inc. (NASDAQ: AGEN) today published a new blog post on The Chairman’s Blog, written by the Company’s Chairman and CEO, Dr. Garo Armen. TheChairmansBlog.com is an exclusive online media publication that enables key executive officers a unique platform to share insights about their company and industry trends.
In his blog Dr. Armen provides details on the recently announced partnership with Incyte Corporation, and speaks to the compelling strategic rationale for the global immuno-oncology alliance. Additionally, he recaps an exciting close to 2014 and describes 2015’s potential for being a transformative year for Agenus. Read the full blog post from Dr. Garo Armen on TheChairmansBlog.com (http://www.thechairmansblog.com/agenus/garo-armen/2015-poised-another-transformative-year-agenus).
About Agenus
Agenus is an immuno-oncology company developing a portfolio of checkpoint modulators (CPMs), heat shock protein peptide-based vaccines and adjuvants. Agenus’ checkpoint modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The company’s proprietary discovery engine Retrocyte DisplayTM is used to generate fully human and humanized therapeutic antibody drug candidates. The Retrocyte DisplayTM platform uses a high-throughput approach incorporating IgG format human antibody libraries expressed in mammalian B-lineage cells. Agenus’ heat shock protein-based vaccines for cancer and infectious disease have completed Phase 2 studies in glioblastoma multiforme, and in the treatment of herpes simplex viral infection. The company’s QS-21 Stimulon(R) adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen Sciences Ireland UC and includes several vaccine candidates in Phase 2, as well as shingles and malaria vaccines which have successfully completed Phase 3 clinical trials. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.
About TheChairmansBlog.com
TheChairmansBlog.com is an exclusive, online media publication where publicly and privately held firms alike share insights about their companies and industries. TheChairmansBlog.com enables upper tier management to discuss issues that are of importance to their stakeholders, shareholders, and interested parties in an informal environment. www.thechairmansblog.com.
(ABGB) Commencement of a Secondary Public Offering of Its Shares of Abengoa Yield
WASHINGTON, Jan. 12, 2015 — Abengoa (MCE:ABG.B/P SM) (Nasdaq:ABGB), today announced the commencement of a public offering of up to 9,200,000 of its ordinary shares in Abengoa Yield by means of an underwritten secondary public offering. The underwriters of the offering will have a 30 day option to purchase up to 1,380,000 additional ordinary shares from Abengoa.
Citigroup and BofA Merrill Lynch are acting as global coordinators of the Offering. HSBC and Banco Santander are acting as joint bookrunners.
The Offering will be made only by means of a prospectus. A copy of the preliminary prospectus, when available, may be obtained without charge from the offices of Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146) or BofA Merrill Lynch, at 222 Broadway, New York, NY 10038, Attn: Prospectus Department, or by emailing dg.prospectus_requests@baml.com.
A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
This communication is directed only at (i) persons who are outside the United Kingdom or (ii) in the United Kingdom, persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), or who are high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as “relevant persons”). Any investment or investment activity to which this communication relates will only be available to and will only be engaged in with, relevant persons. Any person who is not a relevant person must not act or rely on this document or any of its contents.
Forward-Looking Statements
This communication contains forward-looking statements that may state Abengoa’s or its management’s intentions, beliefs, expectations or predictions for the future. Such forward looking statements are subject to certain risks, uncertainties and assumptions, and typically can be identified by the use of words such as “will,” “expect,” “estimate,” “anticipate,” “forecast,” “plan,” “believe,” and similar terms. Although Abengoa believes that its expectations are reasonable, it can give no assurance that these expectations will prove to have been correct, and actual results may vary materially. Factors that could cause actual results to differ materially from those contemplated above include, among others, risks and uncertainties related to the capital markets. Any forward looking information presented herein is made only as of the date of this press release, and we do not undertake any obligation to update or revise any forward-looking information to reflect changes in assumptions, the occurrence of unanticipated events, or otherwise.
CONTACT: Communication Department Patricia Malo de Molina Melendez Tel: +34 954 93 71 11 E-mail: communication@abengoa.com Investor relations Barbara Zubiria Furest. Tel: +34 954 93 71 11 E-mail: ir@abengoa.com
(TOPS) Announces Sale and Lease Back of Two Vessels
ATHENS, Greece, Jan. 12, 2015 — TOP Ships Inc. (Nasdaq:TOPS) (“Top Ships” or the “Company”), an international owner and operator of modern, fuel efficient “ECO” MR tanker vessels focusing on the transportation of petroleum products, announced today that it has entered into a sale and leaseback agreement for two of its vessels: the M/T StenaWeco Energy and the M/T StenaWeco Evolution.
Consummation of the deal is expected to take place during Q1 2015 for both vessels.
Following the sales, the Company will bareboat charter back both vessels and continue to operate them for seven years. In addition, the company has options to buy back the vessels after the third anniversary.
About TOP Ships Inc.
TOP Ships Inc. is an international owner and operator of modern, fuel efficient “ECO” MR tanker vessels focusing on the transportation of petroleum products.
For more information about TOP Ships Inc., visit its website: www.topships.org.
Forward-Looking Statements
Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.
The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. The words “believe,” “anticipate,” “intends,” “estimate,” “forecast,” “project,” “plan,” “potential,” “may,” “should,” “expect” “pending” and similar expressions identify forward-looking statements. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, our management’s examination of historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that we will achieve or accomplish these expectations, beliefs or projections.
In addition to these important factors, other important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include the strength of world economies and currencies, general market conditions, including fluctuations in charter rates and vessel values, failure of a seller to deliver one or more vessels or of a buyer to accept delivery of one or more vessels, inability to procure acquisition financing, default by one or more charterers of our ships, changes in the demand for crude oil and petroleum products, changes in demand for dry bulk shipping capacity, changes in our operating expenses, including bunker prices, drydocking and insurance costs, the market for our vessels, availability of financing and refinancing, changes in governmental rules and regulations or actions taken by regulatory authorities, potential liability from pending or future litigation, general domestic and international political conditions, potential disruption of shipping routes due to accidents or political events, vessels breakdowns and instances of off-hires and other factors. Please see our filings with the Securities and Exchange Commission for a more complete discussion of these and other risks and uncertainties.
CONTACT: Jon Cunningham RedChip Companies, Inc. Tel: 1-800-RED-CHIP (733-2447), ext. 107 Email: jon@redchip.com
(IRMD) Announces 2015 Annual and First Quarter Financial Guidance
- Announces Fourth Quarter 2014 Revenue Estimate
WINTER SPRINGS, Fla., Jan. 12, 2015 — IRADIMED CORPORATION (Nasdaq:IRMD), the only provider of non-magnetic intravenous (IV) infusion pump systems that are safe for use during magnetic resonance imaging (MRI) procedures, today announced its financial guidance for the full year and first quarter 2015.
For the full year 2015, the Company expects to report revenue of $28.0 million to $29.0 million and non-GAAP diluted earnings per share of $0.50 to $0.52. For the first quarter of 2015, the Company expects to report revenue of $6.8 million to $7.0 million and non-GAAP diluted earnings per share of $0.11 to $0.13, an increase of 57% to 86% over the first quarter 2014 non-GAAP diluted earnings per share of $0.07.
The Company expects to report revenue of approximately $3.5 million for the fourth quarter 2014. The Company’s guidance for the fourth quarter was $3.0 million.
The Company’s non-GAAP diluted earnings per share guidance excludes stock-based compensation expense, net of tax, which the Company expects to be approximately $1.1 million and $0.3 million for the full year and first quarter 2015, respectively, and which the Company expects will reduce GAAP diluted earnings per share by approximately $0.09 and $0.02 for the respective periods.
Use of non-GAAP Financial Measures
This release contains financial guidance that excludes stock-based compensation expense, net of tax, which is a non-GAAP financial measure. The Company believes that the presentation of financial guidance excluding stock-based compensation, net of tax, provides meaningful information to both management and investors. Because of varying available valuation methodologies, subjective assumptions and the variety of equity instruments that can impact a company’s non-cash expenses, we believe that providing this non-GAAP financial measure allows for meaningful comparisons between our operating results from period to period. We believe that all of our non-GAAP financial measures are important tools for financial and operational decision making and for evaluating our operating results.
About IRADIMED CORPORATION
IRADIMED CORPORATION is the leading provider of non-magnetic IV infusion pump systems that are safe for use during MRI procedures. Other electromechanical medical devices and pumps contain magnetic and electronic parts that are potentially dangerous to operate in the presence of the powerful magnet that drives an MRI. The Company’s mRidium (3850/3860+) IV pump systems have been designed with non-ferrous parts, ceramic ultrasonic motors, non-magnetic mobile stands and other special features in order to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. The Company’s pump solution provides a seamless approach to providing IV fluids before, during and after an MRI scan, which is important to critically-ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated in order to remain immobile during an MRI scan.
For more information please visit www.iradimed.com. mRidium is a trademark of IRADIMED CORPORATION.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Act of 1995, particularly statements regarding our expectations, beliefs, plans, intentions, future operations, financial condition and prospects, and business strategies. These statements relate to future events or our future financial performance or condition and involve unknown risks, uncertainties and other factors that could cause our actual results, level of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. The risks and uncertainties referred to above include, but are not limited to, risks associated with the Company’s ability to receive clearance of its 510(k) submission, additional actions by or requests from the FDA (including a request to cease domestic distribution of products) and unanticipated costs or delays associated with resolution of these matters; a securities class-action lawsuit that has been filed against the Company in connection with the FDA warning letter; our reliance on a single product; unexpected costs, expenses and diversion of management attention resulting from the FDA warning letter and the related securities class-action lawsuit; potential disruptions in our limited supply chain for our products; actions of the FDA or other regulatory bodies that could delay, limit or suspend product development, manufacturing or sales; the effect of recalls, patient adverse events or deaths on our business; difficulties or delays in the development, production, manufacturing and marketing of new or existing products and services; changes in laws and regulations or in the interpretation or application of laws or regulations.
Further information on these and other factors that could affect the Company’s financial results is included in filings we make with the Securities and Exchange Commission from time to time. All forward-looking statements are based on information available to us on the date hereof, and we assume no obligation to update forward-looking statements.
CONTACT: Media Contact: Chris Scott Chief Financial Officer IRADIMED CORPORATION (407) 677-8022 InvestorRelations@iradimed.com
(ARTX) Division Receives $17 Million in New Orders
ANN ARBOR, Michigan, January 12, 2015 —
Arotech Corporation (Nasdaq GM: ARTX) today announced that its Power Systems Division has recently received $17 million in new orders for batteries and power systems.
Approximately $10 million of the orders was from a foreign Defense Ministry for military batteries and chargers for tactical communication systems. The remaining $7 million was for batteries and chargers for a variety of customers. $1 million worth of the orders has already been delivered.
“This is a very large mix of orders that includes an important order to a prestigious customer,” commented Arotech‘s President and Chief Executive Officer, Steven Esses. “We are pleased with our growing sales to existing as well as new customers, all of whom appreciate the military-grade technology, build quality, and stability of our batteries and power systems. These orders start the year with positive momentum, which I expect will contribute to our anticipated growth in revenue and profit during 2015.”
About Arotech’s Power Systems Division
Arotech’s Power Systems Division is a leading provider of primary and rechargeable batteries and chargers for defense and other military applications and of electronic components and subsystems primarily for military, aerospace and industrial customers. Arotech develops and produces high power zinc-air batteries and is believed to be the sole supplier of this technology to the U.S. military. In addition, Arotech develops high-end primary and secondary batteries and associated chargers, as well as (i) hybrid power generation systems, (ii) smart power subsystems for military vehicles and dismounted applications, and (iii) aircraft and missile systems support for cutting-edge weapons and communications technologies, and has vast experience in working with government agencies, the military and large corporations. The Power Systems Division consists of Electric Fuel Battery Corporation (http://www.efbpower.com), Epsilor-Electric Fuel Ltd. (http://www.epsilor.com ; http://www.electric-fuel.com), and UEC Electronics, LLC (http://www.uec-electronics.com).
About Arotech Corporation
Arotech Corporation is a leading provider of quality defense and security products for the military, law enforcement and homeland security markets, including multimedia interactive simulators/trainers and advanced zinc-air and lithium batteries and chargers. Arotech operates two major business divisions: Training and Simulation, and Power Systems.
Arotech is incorporated in Delaware, with corporate offices in Ann Arbor, Michigan, and research, development and production subsidiaries in Alabama, Michigan, South Carolina and Israel. For more information on Arotech, please visit Arotech’s website at http://www.arotech.com.
Except for the historical information herein, the matters discussed in this news release include forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, readers are cautioned not to place undue reliance on these forward-looking statements, as they are subject to various risks and uncertainties that may cause actual results to vary materially. These risks and uncertainties include, but are not limited to, risks relating to: product and technology development; the uncertainty of the market for Arotech’s products; changing economic conditions; delay, cancellation or non-renewal, in whole or in part, of contracts or of purchase orders (including as a result of budgetary cuts resulting from automatic sequestration under the Budget Control Act of 2011); and other risk factors detailed in Arotech’s most recent Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2013 and in Exhibit 99.3 to Arotech’s Current Report on 8-K, filed on April 1, 2014, and other filings with the Securities and Exchange Commission. Arotech assumes no obligation to update the information in this release. Reference to the Company’s website above does not constitute incorporation of any of the information thereon into this press release.
Investor Relations Contact
For more information on Arotech or investor/public relations, please contact:
Ehud Helft and Kenny Green at GK Investor & Public Relations
Tel: +1-646-201-9246
E-mail: arotech@gkir.com
(FMI) Enters a Broad, Strategic Collaboration with Roche (RHHBY)
Foundation Medicine, Inc. (NASDAQ:FMI) and Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that they will enter into a broad strategic collaboration to further advance Foundation Medicine’s market-leading position in molecular information and genomic analysis while providing Roche a unique opportunity to optimize the identification and development of novel treatment options for cancer patients.
“We are very pleased to enter into this collaboration with Foundation Medicine, which has the potential to improve both the development of medicines and patient care,” said Daniel O’Day, chief operating officer of Roche Pharma. “By combining Foundation Medicine’s pioneering approach to genomics and molecular information with Roche’s expertise in the field of oncology, we can bring personalized healthcare in oncology to the next level.”
The emerging field of molecular information and genomic analysis will play an increasingly important role for future medicines and diagnostic solutions, in particular for cancer patients. Foundation Medicine supports physicians by providing comprehensive molecular information to characterize a tumor that is being matched with approved targeted therapy options and novel treatments in development. Understanding the comprehensive genomic profile of a patient’s disease will enable better personalized healthcare solutions to optimize treatment outcomes for patients with cancer.
“We are excited to announce this strategic collaboration with Roche, which will help accelerate our business, and importantly, represents significant potential for individuals with cancer around the world. We believe that putting molecular information at the center of cancer care will help transform the delivery of care for patients and speed the pace of drug discovery and development,” said Dr. Pellini. “The structure of our agreement with Roche also allows us to maintain the entrepreneurial spirit at Foundation Medicine and ensures that our business model, network of partnerships and objectives are not altered.”
Novel approaches to R&D, Product Development and Commercialization
Under the terms of the R&D collaboration agreement, Roche is committing to R&D funding of potentially more than USD 150 million for a minimum of five years and will contribute its expertise and breadth in oncology. Foundation Medicine will continue to operate independently and will contribute its experience in the development of comprehensive genomic profiling tests for oncology. The initial focus of the R&D collaboration will be on developing genomic profile tests for cancer immunotherapies and for continuous blood-based monitoring.
Roche will be able to utilize Foundation Medicine’s proprietary molecular information platform to standardize clinical trial testing. This aspect of the relationship is designed to enable comparability of clinical trial results for R&D purposes, and ultimately in the clinic. Foundation Medicine’s pharmaceutical services business will not be impacted and could be enhanced as its capabilities increase with the investments and experience in working with Roche as a customer.
The R&D collaboration and Foundation Medicine’s current and future tests are expected to deliver insights to support development of combination therapies, novel targets, more accurate patient population identification and inclusion in clinical trials, and next generation companion diagnostics. The intention is to improve decision making and support optimization of patient care as oncology management becomes more complex.
In addition to the R&D collaboration, both parties also agreed to a commercial collaboration agreement designed to broaden Foundation Medicine’s position across clinical and molecular information markets. Specifically, Roche will obtain rights ex-U.S. (under the Foundation Medicine brand) to existing Foundation Medicine products, as well as to future co-developed products. In the U.S., Roche will engage its medical education team in providing medical information to pathologists. The collaboration agreements will become effective upon the completion of Roche’s direct investment in Foundation Medicine and the tender offer, as described below.
Transaction Structure and Governance
Under the terms of the contemplated transaction, Roche will invest USD 250 million in Foundation Medicine at a per share issuance price of USD 50 (5 million shares) to fund its operations and development. In addition, Roche will commence a tender offer at a per share price of USD 50, which, when combined with Roche’s direct investment in Foundation Medicine, will result in Roche owning a minimum of 52.4% and a maximum of 56.3% of Foundation Medicine on a fully diluted basis. The offer price constitutes a 109% premium over the closing price of last Friday, January 9, 2015.
The completion of Roche’s direct investment in Foundation Medicine, and the successful outcome of the tender offer, as well as the execution of the collaboration agreements are all cross-conditional subject to Foundation Medicine shareholder approval, clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.
The transaction has been unanimously approved by the Foundation Medicine Board of Directors. In addition, Third Rock Ventures, Kleiner Perkins Caufield & Byers and Google Ventures, three shareholders owning approximately 31% of Foundation Medicine equity combined, have entered into a support agreement pursuant to which they have each committed to vote in favor of the transaction and to tender at least a majority of their shareholdings in the tender offer.
Upon the closing, Foundation Medicine’s board of directors will be increased to nine directors and will include three designees of Roche, including Daniel O’Day. Four existing independent directors of Foundation Medicine and Michael Pellini, M.D., will continue as directors and one new independent director will be added. It is anticipated that Alexis Borisy will remain Chairman.
The transaction is expected to close in the second quarter of 2015.
Goldman, Sachs & Co. is acting as financial advisor to Foundation Medicine and Goodwin Procter LLP is acting as legal counsel to Foundation Medicine. Citi is acting as financial advisor to Roche and Davis Polk & Wardwell LLP is acting as legal counsel to Roche.
Conference Call
The management team will host a conference call discussing its collaboration with Roche on Monday, January 12, 2015, at 8:30 a.m. ET. The call can be accessed by dialing (855) 420-0652 (domestic) or (484) 365-2939 (international) five minutes prior to the start of the call and providing the passcode 64129578.
The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website for two weeks following the call.
About Foundation Medicine
Foundation Medicine (NASDAQ: FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company’s clinical assays, FoundationOne for solid tumors and FoundationOne Heme for hematologic malignancies, sarcomas and pediatric cancers, provide a fully informative genomic profile to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Cautionary Statement Regarding Forward-Looking Statements
Statements in this press release may contain, in addition to historical information, certain statements that are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Foundation Medicine has identified some of these forward-looking statements with words like “believe,” “may,” “could,” “would,” “might,” “possible,” “will,” “should,” “expect,” “intend,” “plan,” “anticipate,” or “continue,” the negative of these words, other terms of similar meaning or the use of future dates. Forward-looking statements in this press release include without limitation statements regarding the planned completion of the collaboration between Foundation Medicine and Roche, the tender offer, the issuance of shares of Foundation Medicine common stock to Roche and any of the transactions contemplated by the documents for the proposed transactions. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: uncertainties as to the timing of the transactions; uncertainties as to the percentage of shares of Foundation Medicine stock tendered in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of disruption caused by the transaction making it more difficult to maintain relationships with employees, collaborators, vendors and other business partners; the risk that stockholder litigation in connection with the transaction may result in significant costs of defense, indemnification and liability; the risks that any anticipated product launch or global expansion will be delayed, cancelled or unsuccessful; the unsuccessful realization of Foundation Medicine’s expectations and beliefs regarding the future conduct and growth of Foundation Medicine’s business and the markets in which it operates; and other risks and uncertainties discussed in Foundation Medicine’s filings with the SEC, including the “Risk Factors” sections of Foundation Medicine’s most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, as well as the tender offer documents to be filed by Roche, the Solicitation/Recommendation Statement to be filed by Foundation Medicine and the proxy statement to be filed by Foundation Medicine. Foundation Medicine undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
Important Information and Where to Find It
The tender offer described in this press release (the “Offer”) has not yet commenced, and this press release is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Foundation Medicine or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the United States Securities and Exchange Commission (the “SEC”) by Roche, and a Solicitation/Recommendation Statement on Schedule 14D-9 will be filed with the SEC by Foundation Medicine. The offer to purchase shares of Foundation Medicine common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. Also in connection with the proposed transactions, Foundation Medicine will file a proxy statement with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE TENDER OFFER STATEMENT, THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER AND THE PROXY STATEMENT, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the tender offer which will be named in the tender offer statement. Copies of Foundation Medicine’s filings with the SEC may be obtained free of charge at the “Investors & Press” section of Foundation Medicine’s website at www.foundationmedicine.com or by contacting investor relations at 617-418-2283.
Certain Information Regarding Participants
Foundation Medicine and its directors, executive officers and other members of its management and employees may be deemed under SEC rules to be participants in the solicitation of proxies of Foundation Medicine’s stockholders in connection with the proposed transactions. Information concerning the interests of Foundation Medicine’s participants in the solicitation, which may, in some cases, be different than those of Foundation Medicine’s stockholders generally, is set forth in materials filed by Foundation Medicine with the SEC, including in Foundation Medicine’s definitive proxy statement filed with the SEC on April 30, 2014, and will be set forth in the proxy statement relating to the transactions when they become available. These documents can be obtained free of charge from the sources indicated above.
All trademarks used or mentioned in this release are protected by law.
Media Contact:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
dan@purecommunicationsinc.com
or
Investor Contact:
Foundation Medicine
Khaled Habayeb, 617-418-2283
ir@foundationmedicine.com
(KITE) Expands Senior Management Team
SANTA MONICA, Calif., Jan. 9, 2015 — Kite Pharma, Inc., (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced the appointment of Claudine Prowse, Ph.D., to the newly created position of Senior Vice President, Corporate Communications and Investor Relations (IR). Dr. Prowse will be primarily responsible for driving the Company’s communication strategy and initiatives. She will report to Ms. Cynthia M. Butitta, Chief Financial Officer and Chief Operating Officer.
“On behalf of management and the Board of Kite, I am pleased to welcome Claudine to our leadership team,” said Ms. Butitta. “Claudine is an accomplished communications executive with a keen sense of the critical role science and innovation play in creating value, who has deep experience in working with a broad base of stakeholders including stockholders, patients and providers.”
Dr. Prowse has 15 years of experience in the healthcare sector in IR, Corporate Communications, and Institutional Equities Research. Most recently, Dr. Prowse served as the Vice President of Investor Relations at Biogen Idec (Nasdaq:BIIB). She holds a B.S. in Biomedical Engineering from the University of California, San Diego (UCSD) School of Engineering and a Ph.D. in Biomedical Sciences from the UCSD School of Medicine.
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on eACT™ designed to restore the immune system’s ability to recognize and eradicate tumors. In partnership with the NCI Surgery Branch through a Cooperative Research and Development Agreement (CRADA), Kite is advancing a pipeline of proprietary eACT™ peripheral blood product candidates, both CAR (chimeric antigen receptor) and TCR (T cell receptor) products, directed to a wide range of cancer indications. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and willingness of the NCI to continue research and development activities relating to eACT™ pursuant to the CRADA. Various factors may cause differences between Kite’s expectations and actual results as discussed in greater detail in Kite’s filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended September 30, 2014. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CONTACT: Kite Contacts: Claudine Prowse SVP, Corporate Communications and Investor Relations cprowse@kitepharma.com Cynthia M. Butitta Chief Financial Officer and Chief Operating Officer 310-824-9999 For Media: Justin Jackson Burns McClellan (212) 213-0006 jjackson@burnsmc.com
(VOXX) to Present at the 17th Annual Needham Growth Conference
HAUPPAUGE, N.Y., Jan. 9, 2015 — VOXX International Corporation (Nasdaq: VOXX) today announced that its President and Chief Executive Officer, Pat Lavelle will be presenting at the 17th Annual Needham Growth Conference on Wednesday, January 14, 2014. The investor conference is being held at the New York Palace Hotel located in New York City and VOXX International will be presenting at 2:50 p.m. Eastern.
Mr. Lavelle, along with the Company’s Chairman, John Shalam and EVP and Chief Financial Officer, Michael Stoehr will also be in attendance, and meeting with investors throughout the day. Those interested in setting up a briefing should contact their Needham client representative, or contact VOXX’s Investor Relations department.
The presentation will be available via a live audio webcast. On the day of the conference, the webcast and the accompanying presentation materials can be found on the Company’s website in the Investor Relations section under the “Events and Presentations” tab or by visiting the following link: http://wsw.com/webcast/needham69/voxx. Additionally, a replay of the webcast will be available shortly after the live presentation and will be archived on the Company’s website for 90 days.
About VOXX International Corporation:
VOXX International Corporation (NASDAQ:VOXX) has grown into a worldwide leader in many automotive and consumer electronics and accessories categories, as well as premium high-end audio. Today, VOXX International Corporation has an extensive distribution network that includes power retailers, mass merchandisers, 12-volt specialists and most of the world’s leading automotive manufacturers. The Company has an international footprint in Europe, Asia, Mexico and South America, and a growing portfolio, which now comprises over 30 trusted brands. Among the key domestic brands are Klipsch®, RCA®, Invision®, Jensen®, Audiovox®, Terk®, Acoustic Research®, Advent®, Code Alarm®, CarLink®, 808®, AR for Her®, and Prestige®. International brands include Hirschmann Car Communication®, Klipsch®, Jamo®, Energy®, Mirage®, Mac Audio®, Magnat®, Heco®, Schwaiger®, Oehlbach® and Incaar™. For additional information, please visit our Web site at www.voxxintl.com.
Investor and Media Relations Contact:
Glenn Wiener
GW Communications (for VOXX)
Tel: 212-786-6011
Email: gwiener@GWCco.com
(SCYX) FDA Fast Track Designation for Oral Formulation of SCY-078 In Invasive Fungal Infections
RESEARCH TRIANGLE PARK, N.C., Jan. 9, 2015 — Drug discovery and development company SCYNEXIS, Inc. (Nasdaq:SCYX) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for the oral formulation of SCY-078, the Company’s novel antifungal product in development for the treatment of invasive Candidiasis, including Candidemia and invasive Aspergillosis. SCYNEXIS is currently screening patients for a Phase 2 study of the oral formulation of SCY-078 and expects to enroll the first patient in the first quarter of 2015.
“This Fast Track designation, coupled with our prior receipt of QIDP designation, allows for an accelerated path to approval and underscores the FDA’s understanding of the critical need for new and varied treatments for life-threatening invasive fungal infections,” said Yves J. Ribeill, Ph.D., President and Chief Executive Officer of SCYNEXIS. “We now have multiple trial sites open and we look forward to reporting complete data in the first half of 2016.”
The FDA’s Fast Track Drug Development Program is a process designed to facilitate the development and expeditious review of drugs to treat serious conditions and fill an unmet medical need. This designation allows for companies to interact with the FDA review team frequently to discuss critical development issues such as study design, required safety data necessary to support approval, and structure and content of a New Drug Application. Additionally, should the FDA determine that a Fast Track product may be effective after their preliminary evaluation of clinical data submitted by a sponsor, the FDA may also consider reviewing portions of a marketing application before the sponsor submits the complete application.
About SCY-078
SCY-078 (formerly MK-3118) is an oral glucan synthase inhibitor being developed for the treatment of invasive fungal infections including Candidemia and invasive Aspergillosis. SCY-078 is a semi-synthetic derivative of the natural product enfumafungin—a structurally distinct class of glucan synthase inhibitors. Glucan synthase inhibitors have been very effective in treating invasive fungal infections in a hospital setting, but are currently only available in intravenous formulations. The FDA designated SCY-078 as a Qualified Infectious Disease Product (QIDP) for oral use for the indications of invasive Candidiasis, including Candidemia, and invasive Aspergillosis. SCYNEXIS is developing both oral and intravenous formulations of SCY-078.
About Invasive Fungal Infections
Invasive fungal infections (IFI) are serious, often life-threatening infections caused by a variety of fungal species. The most common invasive fungal infections stem from Candidiasis and Aspergillosis, responsible for approximately 85 percent of all invasive fungal infections in the U.S. and Europe. The incidence of invasive fungal infections has increased significantly over the past two decades, as the populations of patients at risk have continued to rise. Morbidity and mortality remain high despite the currently available antifungal agents. Because there are limited treatment options, and they are used widely, there has been an increase in the number of infections due to drug-resistant strains.
About SCYNEXIS
SCYNEXIS is a pharmaceutical company committed to the discovery, development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, as an oral and intravenous (IV) drug for the treatment of serious and life-threatening invasive fungal infections in humans. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding matters that are expected to occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in SCYNEXIS’s filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT: Media Relations Heather Savelle MacDougall Biomedical Communications Tel: 781-235-3060 E-mail: hsavelle@macbiocom.com Investor Relations Jillian Connell The Trout Group LLC Tel: 646-378-2956 E-mail: jconnell@troutgroup.com SCYNEXIS, Inc. Contact Chuck Osborne Chief Financial Officer Tel: 919-544-8600 E-mail: chuck.osborne@scynexis.com
(ADHD) Prices Public Offering of Ordinary Shares
TEL AVIV, Israel, Jan. 9, 2015 — Alcobra Ltd. (Nasdaq:ADHD) announced the pricing of its previously announced underwritten public offering of 6,500,000 ordinary shares at an offering price of $4 per share. Gross proceeds from the sale of the shares by Alcobra before underwriting discounts and commissions and other offering expenses are expected to be approximately $26 million. The offering is expected to close on January 14, 2015, subject to customary closing conditions. In connection with the offering, Alcobra has also granted the underwriters a 30-day option to purchase up to an additional 15% of the ordinary shares offered to the public to cover over-allotments, if any.
Alcobra is developing MDX, a proprietary non-stimulant for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and other cognitive disorders. Alcobra plans to use the net proceeds from the offering to fund its future clinical development program and for general corporate purposes.
Piper Jaffray & Co. is acting as the sole manager.
The shares are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-197411) filed pursuant to the Securities Act of 1933, as amended, which was previously filed with, and declared effective by, the Securities and Exchange Commission (SEC). A prospectus supplement related to the filing will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may be obtained by contacting Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924 or by e-mail at prospectus@pjc.com
About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX, to treat cognitive disorders including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MDX has completed multiple Phase II studies and a Phase III study in adults with ADHD. The company is conducting separate Phase IIb trials in pediatric ADHD and Fragile X Syndrome. For more information please visit the Company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Alcobra’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the Company’s public offering, its anticipated closing date and planned use of the net proceeds from the offering. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results referred to in this press release would be interpreted differently in light of additional research or otherwise. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including market conditions and the satisfaction of customary closing conditions related to the proposed offering, and other risk factors discussed in Alcobra’s prospectus supplement and in Alcobra’s Annual Report on Form 20-F for the fiscal year ended December 31, 2013 filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
CONTACT: U.S. Investor Contacts LifeSci Advisors, LLC Michael Rice 646-597-6979 mrice@lifesciadvisors.com Media Inquiries Sam Brown, Inc. Mike Beyer 773-463-4211 mikebeyer@sambrown.com Israel Investor Contact: Alcobra Investor Relations Debbie Kaye +972-72 2204661 debbie@alcobra-pharma.com
(EDAP) Focal One HIFU Device Approved by Health Canada
LYON, France, Jan. 9, 2015 — EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that its Focal One HIFU device has been approved by Health Canada. With this approval, the Company is able to market the Focal One device for the treatment of prostate cancer in Canada.
Marc Oczachowski, EDAP’s Chief Executive Officer, commented, “Health Canada approval of Focal One, our revolutionary tool for the focal treatment of prostate cancer, represents an important milestone for EDAP. Moreover, this is the first regulatory approval for our Focal One device in the Americas, and a key step forward in our overall regulatory strategy as we work to expand Focal One’s global footprint and bring our innovative cancer therapies to a growing number of patients worldwide.”
Oczachowski continued: “In the 18 months since we received EU marketing approval, the enthusiastic response from the European urology community has validated our belief in the potential of focal therapy for prostate cancer and, more specifically, our Focal One system. In a relatively short time, the technology has been adopted by some of Europe’s leading prostate cancer Hospitals. We look forward to a similar reception as we establish our North American presence via the Canadian market.”
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment, Ablatherm-HIFU is approved and commercialized in Europe as a treatment for prostate cancer and is currently under regulatory review in the U.S. following submission of the Pre-Market Approval Application in February 2013 after the completion of a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA. In March 2013, the Company introduced a new innovative HIFU device, the Focal One® dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment (the Sonolith® range) for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.
Forward-Looking Statements
In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others the uncertainties of the U.S. FDA approval process, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device.,. Factors that may cause such a difference also may include, but are not limited to, those described in the Company’s filings with the Securities and Exchange Commission and in particular, in the sections “Cautionary Statement on Forward-Looking Information” and “Risk Factors” in the Company’s Annual Report on Form 20-F. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.
CONTACT: Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 72 bconfort@edap-tms.com Investors: Lee Roth The Ruth Group 646-536-7012 lroth@theruthgroup.com
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